<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712061</url>
  </required_header>
  <id_info>
    <org_study_id>B1261007</org_study_id>
    <secondary_id>2012-003332-23</secondary_id>
    <nct_id>NCT01712061</nct_id>
  </id_info>
  <brief_title>A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Once-daily Administration Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects&#xD;
      with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a&#xD;
      surrogate for improved glomerular filtration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in UACR at Weeks 4, 8 and 16</measure>
    <time_frame>Baseline, Weeks 4, 8 and 16</time_frame>
    <description>The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Weeks 4, 8, 12 and 16</time_frame>
    <description>The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Week 1, 4, 8, 12 and 16</time_frame>
    <description>eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16</measure>
    <time_frame>Baseline, Week 12, and Week 16</time_frame>
    <description>Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Week 1, 4, 8, 12 and 16</time_frame>
    <description>Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Cystatin C at Weeks 12 and 16</measure>
    <time_frame>Baseline, Week 12, and Week 16</time_frame>
    <description>Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Weeks 4, 8, 12 and 16</time_frame>
    <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12</measure>
    <time_frame>1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Weeks 1, 4, 8, 12 and 16</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Weeks 1, 4, 8, 12 and 16</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16</measure>
    <time_frame>Baseline, Weeks 1, 4, 8, 12 and 16</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern</measure>
    <time_frame>Baseline up to Week 16 (follow-up visit)</time_frame>
    <description>The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings</measure>
    <time_frame>Baseline, Weeks 1, 4 and 12</time_frame>
    <description>Criteria for potentially clinically important ECG values were defined as: PR interval &gt;=300 milliseconds (msec) or &gt;=25%/50% increase when baseline is &gt;200 msec and ≥50% increase when baseline is less than or equal to (&lt;=)200 msec; QRS interval &gt;=140 msec or &gt;=50% increase from baseline (IFB); QTc &gt;=450 msec or &gt;=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) &gt;=450 msec or &gt;=30 msec increase.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 28 days after last study drug administration</time_frame>
    <description>An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Increased Fasting Blood Glucose</measure>
    <time_frame>Baseline up to Week 16 (follow-up visit)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>Diabetic Nephropathy</condition>
  <arm_group>
    <arm_group_label>Arm 1 PF-04634817</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04634817</intervention_name>
    <description>Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function</description>
    <arm_group_label>Arm 1 PF-04634817</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function</description>
    <arm_group_label>Arm 2 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based&#xD;
             on an eGFR of 20-75 mL/min/1.73m2.&#xD;
&#xD;
          -  Evidence of persistent, overt albuminuria; defined as a UACR &gt;=300 mg/g (&gt;=33.9&#xD;
             mg/mmol) or UPCR &gt;=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.&#xD;
&#xD;
          -  Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB,&#xD;
             which may also include an aldosterone antagonist in double RAAS but not triple RAAS&#xD;
             inhibitor therapy) for at least 3 months before screening and to be maintained for the&#xD;
             duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.&#xD;
&#xD;
          -  Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD),&#xD;
             severe peripheral vascular disease (PVD) or obstructive uropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Investigations, Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North America Research Institute</name>
      <address>
        <city>Azusa</city>
        <state>California</state>
        <zip>91702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Kidney Specialists</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes/Lipid Management and Research Center</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tower Nephrology Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richard S. Cherlin, MD</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Clinical Research</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Oasis Healthcare Medical Group</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Coast Nephrology</name>
      <address>
        <city>Salinas</city>
        <state>California</state>
        <zip>93901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Kidney Specialists</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver/University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Coast Endocrine and Diabetes Center</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Continental Research Corp.</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Research Associate, Inc.</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean Blue Medical Research Center, Inc</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prestige Clinical Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology Associates of South Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tellus Clinical Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes Care Center</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Coast Kidney Center</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Clinical Research, Inc.</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pines Clinical Research, Inc.</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Clinic, LLC</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Four Rivers Clinical Research, Inc.</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent City Clinical Research Center</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTRC, Interim LSU Public Hospital</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy Department, Interim LSU Public Hospital</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. Kaldun Nossuli MD Research</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western New England Renal and Transplant Associates, PC</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hurley Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Medical Research, MI, Inc.</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Troy Internal Medicine, PC</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consultants, LLC</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creighton Diabetes Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Medicine Associates</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital, Division of Nephrology and Hypertension</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital, Pharmacy Department</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northport VA Medical Sciences Center</name>
      <address>
        <city>Northport</city>
        <state>New York</state>
        <zip>11768</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Kidney and Hypertension Associates, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University Nephrology Research</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Down East Medical Associates, P.A.</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare/Research</name>
      <address>
        <city>Statesville</city>
        <state>North Carolina</state>
        <zip>28625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brookview Hills Research Associates, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BRAHN-Hypertension and Nephrology, Inc</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Carolina Nephrology and Hypertension Center, Inc.</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Endocrine Clinic, PC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology Associates, P.C.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Clinical Research</name>
      <address>
        <city>Greenville</city>
        <state>Texas</state>
        <zip>75402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Nephrology Associates, LLP</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Houston Research LTD</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Nephrology Associates, LLP</name>
      <address>
        <city>Richmond</city>
        <state>Texas</state>
        <zip>77469</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Advancement Center, PLLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Briggs Clinical Research, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Kidney Disease Center Physicians Group, P.L.L.C.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Nephrology Associates, LLP</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Utah Kidney and Hypertension</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burke Internal Medicine &amp; Research</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Northern Virginia, Inc.</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manassas Clinical Research Center</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zablocki Veterans Affairs Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Renal Junin S.R.L.</name>
      <address>
        <city>Junin</city>
        <state>Buenos Aires</state>
        <zip>6000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>B7600DHK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Clinicas Quilmes S.R.L</name>
      <address>
        <city>Quilmes</city>
        <state>Buenos Aires</state>
        <zip>B1878GEG</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Cardiologia de Corrientes &quot;Juana Francisca Cabral&quot;</name>
      <address>
        <city>Corrientes</city>
        <zip>W3400AMZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Clinicas del Litoral S.R.L.</name>
      <address>
        <city>Santa Fe</city>
        <zip>3000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CETENE S.A. - Centro de Nefrologia y Dialisis</name>
      <address>
        <city>Tucumán</city>
        <zip>T4000IIO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Nephrology</name>
      <address>
        <city>New Lambton</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital, Department of Renal Medicine</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast Hospital &amp; Health Service</name>
      <address>
        <city>Nambour</city>
        <state>Queensland</state>
        <zip>4560</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Diabetes.ca</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Co-Medica Research Network Inc.</name>
      <address>
        <city>Courtice</city>
        <state>Ontario</state>
        <zip>L1E 3C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OTT Healthcare Incorporated</name>
      <address>
        <city>Scarborough</city>
        <state>Ontario</state>
        <zip>M1H 3G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Stephen S. Chow Medicine Professional Corporation</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4C 5T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto East General Medical Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4C 5T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Clinique de Laval</name>
      <address>
        <city>Laval</city>
        <state>Quebec</state>
        <zip>H7T 2P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve-Rosemont-Nephrology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Du Sacre-Coeur de Montreal Centre de recherche</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pro-Recherche</name>
      <address>
        <city>St-Romuald</city>
        <state>Quebec</state>
        <zip>G6W 5M6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dialysezentrum Elsterland</name>
      <address>
        <city>Herzberg</city>
        <state>Brandenburg</state>
        <zip>04916</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Haematologie/Onkologie/Diabetologie</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsmedizin Berlin - Charite Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GWT-TUD GmbH</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Karlstrasse GmbH</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40210</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien</name>
      <address>
        <city>Falkensee</city>
        <zip>14612</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrologisches Zentrum Hoyerswerda</name>
      <address>
        <city>Hoyerswerda</city>
        <zip>02977</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum Klinische Studien Neuwied</name>
      <address>
        <city>Neuwied</city>
        <zip>D-56564</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetologische Schwerpunktpraxis</name>
      <address>
        <city>Schwabenheim</city>
        <zip>55270</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medicine and Therapeutics, Prince of Wales Hospital,</name>
      <address>
        <city>Shatin, New Territories</city>
        <state>Hong Kong SAR</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medicine and Therapeutics</name>
      <address>
        <city>Shatin, New Territories</city>
        <state>Hong Kong SAR</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Consorziale Policlinico di Bari</name>
      <address>
        <city>Bari</city>
        <state>BA</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Versilia</name>
      <address>
        <city>Lido Camaiore. (Lucca)</city>
        <state>Lucca</state>
        <zip>55041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>*Ospedale Versilia</name>
      <address>
        <city>Lido di Camaiore (LUCCA)</city>
        <state>Lucca</state>
        <zip>55043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Versilia</name>
      <address>
        <city>Lido di Camaiore (LUCCA)</city>
        <state>Lucca</state>
        <zip>55043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <state>MO</state>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedali Riuniti di Foggia</name>
      <address>
        <city>Foggia</city>
        <zip>71100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Alessandro Manzoni</name>
      <address>
        <city>Lecco</city>
        <zip>23900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unita Cardiometabolica e Trials Clinici</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University College of Medicine, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>156-755</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universiti Sains Malaysia</name>
      <address>
        <city>Kubong Kerian</city>
        <state>Kelantan</state>
        <zip>16150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Taiping</name>
      <address>
        <city>Taiping</city>
        <state>Perak</state>
        <zip>34000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Selayang Hospital</name>
      <address>
        <city>Batu Caves</city>
        <state>Selangor</state>
        <zip>68100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa de Diabetes y Nutricion</name>
      <address>
        <city>Lima</city>
        <zip>17</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio</name>
      <address>
        <city>Lima</city>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL</name>
      <address>
        <city>Lima</city>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Maison de Sante ¿ Sede este</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 33</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Virgen Maria Auxiliadora</name>
      <address>
        <city>Piura</city>
        <zip>073</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowskie Centrum Medyczne Sp. z.o.o.</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stacja Dializ</name>
      <address>
        <city>Golub-Dobrzyn</city>
        <zip>87-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LANDA Specjalistyczne Gabinety Lekarskie</name>
      <address>
        <city>Krakow</city>
        <zip>30-015</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCM Sp. z.o.o</name>
      <address>
        <city>Krakow</city>
        <zip>31-559</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek</name>
      <address>
        <city>Lodz</city>
        <zip>92-013</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ TRI-medica</name>
      <address>
        <city>Lodz</city>
        <zip>93-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KO-MED, Central Kliniczne Sp. z.o.o</name>
      <address>
        <city>Zamosc</city>
        <zip>22-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ponce School of Medicine - CAIMED Center</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Sciences Campus University of Puerto Rico</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spital Clinic Municipal &quot;Dr. Gavril Curteanu&quot; Oradea</name>
      <address>
        <city>Oradea</city>
        <state>jud. Bihor</state>
        <zip>410469</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul National de Diabet, Nutritie si Boli Metabolice</name>
      <address>
        <city>Bucuresti</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice</name>
      <address>
        <city>Ploiesti</city>
        <zip>100018</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Timisoara</name>
      <address>
        <city>Timisoara</city>
        <zip>300736</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parc de Salut Mar. Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1261007&amp;StudyName=A%20Phase%202%20Multi-Center%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20A%20Chemokine%20CCR2/5%20Receptor%20Antagonist%20In%20Adults%20With%20Type%202%20D</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>September 22, 2015</results_first_submitted>
  <results_first_submitted_qc>September 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 21, 2015</results_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic nephropathy</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>albuminuria</keyword>
  <keyword>chemokine antagonist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Diabetic Nephropathies</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The primary entry criterion for participants was based on presence of macroalbuminuria (urine albumin to creatinine ratio [UACR] greater than or equal to (&gt;=)300 milligrams per gram (mg/g).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PF-04634817 150 mg</title>
          <description>Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (&lt;)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>PF-04634817 200 mg</title>
          <description>Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="140"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="114"/>
                <participants group_id="P3" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Meet Entrance Criteria</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Medication Error Without Associated AE</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PF-04634817 200 mg/150 mg</title>
          <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="170"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="226"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less than (&lt;) 18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-44 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12</title>
        <description>The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12</title>
          <description>The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.</description>
          <population>The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>percent (%)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.27" spread="5.43" lower_limit="3.14" upper_limit="24.62"/>
                    <measurement group_id="O2" value="5.02" spread="6.87" lower_limit="-7.90" upper_limit="18.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Ratio of geometric mean changes</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in UACR at Weeks 4, 8 and 16</title>
        <description>The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.</description>
        <time_frame>Baseline, Weeks 4, 8 and 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in UACR at Weeks 4, 8 and 16</title>
          <description>The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>mg/millimolar creatinine (mmolCr)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=157,50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.41" spread="96"/>
                    <measurement group_id="O2" value="121.80" spread="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=148,46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="66"/>
                    <measurement group_id="O2" value="0.91" spread="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=134,43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="62"/>
                    <measurement group_id="O2" value="0.94" spread="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=126,37)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="72"/>
                    <measurement group_id="O2" value="0.92" spread="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16</title>
        <description>The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.</description>
        <time_frame>Baseline, Weeks 4, 8, 12 and 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16</title>
          <description>The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>mg/mmolCr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=155,49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185.42" spread="97"/>
                    <measurement group_id="O2" value="176.31" spread="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=143,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="47"/>
                    <measurement group_id="O2" value="0.92" spread="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=130,42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="50"/>
                    <measurement group_id="O2" value="0.94" spread="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=125,42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="58"/>
                    <measurement group_id="O2" value="0.92" spread="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=125,36)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="58"/>
                    <measurement group_id="O2" value="0.92" spread="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16</title>
        <description>eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR</description>
        <time_frame>Baseline, Week 1, 4, 8, 12 and 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16</title>
          <description>eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=159,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.80" spread="12.18"/>
                    <measurement group_id="O2" value="41.65" spread="13.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 1 (n=157,50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" spread="5.80"/>
                    <measurement group_id="O2" value="-0.35" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=157,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.07" spread="5.37"/>
                    <measurement group_id="O2" value="-1.32" spread="5.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=147,47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.60" spread="5.34"/>
                    <measurement group_id="O2" value="-2.15" spread="6.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=136,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" spread="5.70"/>
                    <measurement group_id="O2" value="-1.03" spread="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=134,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.14" spread="6.42"/>
                    <measurement group_id="O2" value="-1.18" spread="5.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16</title>
        <description>Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.</description>
        <time_frame>Baseline, Week 12, and Week 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16</title>
          <description>Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=159,50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.28" spread="14.22"/>
                    <measurement group_id="O2" value="45.36" spread="14.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=135,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.10" spread="6.30"/>
                    <measurement group_id="O2" value="-0.70" spread="5.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=134,43)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.27" spread="6.77"/>
                    <measurement group_id="O2" value="-0.91" spread="6.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16</title>
        <description>Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.</description>
        <time_frame>Baseline, Week 1, 4, 8, 12 and 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16</title>
          <description>Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>milligrams per deciliter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=159,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" spread="0.51"/>
                    <measurement group_id="O2" value="1.77" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 1 (n=158,50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.22"/>
                    <measurement group_id="O2" value="0.03" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=157,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.21"/>
                    <measurement group_id="O2" value="0.11" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=147,47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.21"/>
                    <measurement group_id="O2" value="0.09" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=137,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.24"/>
                    <measurement group_id="O2" value="0.08" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=134,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.30"/>
                    <measurement group_id="O2" value="0.09" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Cystatin C at Weeks 12 and 16</title>
        <description>Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.</description>
        <time_frame>Baseline, Week 12, and Week 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Cystatin C at Weeks 12 and 16</title>
          <description>Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=159,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="0.43"/>
                    <measurement group_id="O2" value="1.52" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=136,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.25"/>
                    <measurement group_id="O2" value="0.03" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=134,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.26"/>
                    <measurement group_id="O2" value="0.06" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16</title>
        <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.</description>
        <time_frame>Baseline, Weeks 4, 8, 12 and 16</time_frame>
        <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16</title>
          <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.</description>
          <population>The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=159,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.51" spread="1.22"/>
                    <measurement group_id="O2" value="7.91" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=157,51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.46"/>
                    <measurement group_id="O2" value="-0.04" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=147,46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.64"/>
                    <measurement group_id="O2" value="-0.08" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=137,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.76"/>
                    <measurement group_id="O2" value="-0.06" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=133,44)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.89"/>
                    <measurement group_id="O2" value="-0.04" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12</title>
        <time_frame>1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12</time_frame>
        <population>The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 150 mg</title>
            <description>Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (&lt;)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-04634817 200 mg</title>
            <description>Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12</title>
          <population>The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: 1 Hour Post-Dose (n=29,124)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="434.5" spread="65"/>
                    <measurement group_id="O2" value="524.4" spread="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 2 Hours Post-Dose (n=30,139)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="579.3" spread="37"/>
                    <measurement group_id="O2" value="602.9" spread="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 4 Hours Post-Dose (n=29,137)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497.4" spread="38"/>
                    <measurement group_id="O2" value="547.7" spread="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1: Pre-Dose (n=28,131)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="294.4" spread="60"/>
                    <measurement group_id="O2" value="231.2" spread="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1: 2 Hours Post-Dose (n=28,132)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="884.8" spread="42"/>
                    <measurement group_id="O2" value="865.0" spread="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: Pre-Dose (n=25,126)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="231.3" spread="51"/>
                    <measurement group_id="O2" value="239.5" spread="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4: 2 Hours Post-Dose (n=24,122)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="785.8" spread="45"/>
                    <measurement group_id="O2" value="918" spread="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Pre-Dose (n=23,113)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310.2" spread="79"/>
                    <measurement group_id="O2" value="245.2" spread="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: 2 Hours Post-Dose (n=23,114)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="730.0" spread="70"/>
                    <measurement group_id="O2" value="895" spread="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=20,113)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="320.1" spread="75"/>
                    <measurement group_id="O2" value="252.3" spread="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16</title>
        <time_frame>Baseline, Weeks 1, 4, 8, 12 and 16</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16</title>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
          <units>millimeters of mercury (mm Hg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine SBP: Baseline (n=168,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.4" spread="13.96"/>
                    <measurement group_id="O2" value="139.9" spread="13.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP:Change From Baseline Week 1 (n=164,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="12.75"/>
                    <measurement group_id="O2" value="-1.6" spread="12.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP:Change From Baseline Week 4 (n=154,49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="15.43"/>
                    <measurement group_id="O2" value="-1.6" spread="14.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP:Change From Baseline Week 8 (n=142,47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="12.94"/>
                    <measurement group_id="O2" value="-1.1" spread="13.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP:Change From Baseline Week 12 (n=134,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="13.28"/>
                    <measurement group_id="O2" value="-1.3" spread="13.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP:Change From Baseline Week 16 (n=138,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="15.14"/>
                    <measurement group_id="O2" value="-0.3" spread="14.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP: Baseline (n=168,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" spread="8.97"/>
                    <measurement group_id="O2" value="77.1" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP:Change From Baseline Week 1 (n=164,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="6.94"/>
                    <measurement group_id="O2" value="-2.7" spread="7.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP:Change From Baseline Week 4 (n=154,49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="8.23"/>
                    <measurement group_id="O2" value="-1.8" spread="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP:Change From Baseline Week 8 (n=142,47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="7.46"/>
                    <measurement group_id="O2" value="-1.5" spread="7.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP:Change From Baseline Week 12 (n=134,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="6.88"/>
                    <measurement group_id="O2" value="-0.2" spread="6.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP:Change From Baseline Week 16 (n=138,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="7.98"/>
                    <measurement group_id="O2" value="0.9" spread="8.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16</title>
        <time_frame>Baseline, Weeks 1, 4, 8, 12 and 16</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16</title>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
          <units>beats per minute (bpm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=168,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7" spread="9.74"/>
                    <measurement group_id="O2" value="69.3" spread="9.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 1 (n=164,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="5.86"/>
                    <measurement group_id="O2" value="-0.7" spread="5.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=154,49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="6.01"/>
                    <measurement group_id="O2" value="-1.0" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=142,47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="6.54"/>
                    <measurement group_id="O2" value="1.4" spread="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=134,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="7.03"/>
                    <measurement group_id="O2" value="0.5" spread="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=138,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="8.22"/>
                    <measurement group_id="O2" value="-0.1" spread="6.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16</title>
        <time_frame>Baseline, Weeks 1, 4, 8, 12 and 16</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16</title>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
          <units>kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=167,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8" spread="23.97"/>
                    <measurement group_id="O2" value="95.1" spread="25.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 1 (n=163,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.03"/>
                    <measurement group_id="O2" value="0.3" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 4 (n=153,49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="1.74"/>
                    <measurement group_id="O2" value="0.4" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 8 (n=141,47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="2.45"/>
                    <measurement group_id="O2" value="0.7" spread="2.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 12 (n=134,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="2.66"/>
                    <measurement group_id="O2" value="0.7" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Week 16 (n=137,45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.79"/>
                    <measurement group_id="O2" value="0.2" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern</title>
        <description>The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).</description>
        <time_frame>Baseline up to Week 16 (follow-up visit)</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern</title>
          <description>The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).</description>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings</title>
        <description>Criteria for potentially clinically important ECG values were defined as: PR interval &gt;=300 milliseconds (msec) or &gt;=25%/50% increase when baseline is &gt;200 msec and ≥50% increase when baseline is less than or equal to (&lt;=)200 msec; QRS interval &gt;=140 msec or &gt;=50% increase from baseline (IFB); QTc &gt;=450 msec or &gt;=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) &gt;=450 msec or &gt;=30 msec increase.</description>
        <time_frame>Baseline, Weeks 1, 4 and 12</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings</title>
          <description>Criteria for potentially clinically important ECG values were defined as: PR interval &gt;=300 milliseconds (msec) or &gt;=25%/50% increase when baseline is &gt;200 msec and ≥50% increase when baseline is less than or equal to (&lt;=)200 msec; QRS interval &gt;=140 msec or &gt;=50% increase from baseline (IFB); QTc &gt;=450 msec or &gt;=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) &gt;=450 msec or &gt;=30 msec increase.</description>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maximum PR Interval &gt;=300 msec (n=164,55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QRS Complex &gt;=140 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QT Interval &gt;=500 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTc Interval 450-&lt;480 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTc Interval 480-&lt;500 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTc Interval &gt;=500 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF Interval 450-&lt;480 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF Interval 480-&lt;500 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF Interval &gt;=500 msec (n=169,56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval &gt;=25/50% IFB (n=163,53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Complex &gt;=50% IFB (n=169,55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTc Interval 30-&lt;60 msec IFB (n=169,55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTc Interval &gt;=60 msec IFB (n=169,55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval 30-&lt;60 msec IFB (n=169,55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval &gt;=60 msec IFB (n=169,55)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.</description>
        <time_frame>Baseline up to 28 days after last study drug administration</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.</description>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Increased Fasting Blood Glucose</title>
        <time_frame>Baseline up to Week 16 (follow-up visit)</time_frame>
        <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04634817 200 mg/150 mg</title>
            <description>Participants were dosed orally at 150 mg (eGFR 20-&lt;30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Increased Fasting Blood Glucose</title>
          <population>The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="167"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 28 days after last study drug administration</time_frame>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>PF-04634817 150 mg</title>
          <description>Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (&lt;)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>PF-04634817 200 mg</title>
          <description>Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants were dosed orally with matching placebo tablets QD for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Erythrodermic psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Homicide</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="140"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712061
org study id: B1261007
secondary id: 2012-003332-23
nct id: NCT01712061
lead sponsor: 
has dmc: No
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects
      with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a
      surrogate for improved glomerular filtration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
time frame: Baseline and Week 12
description: The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
measure: Change From Baseline in UACR at Weeks 4, 8 and 16
time frame: Baseline, Weeks 4, 8 and 16
description: The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
measure: Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16
time frame: Baseline, Weeks 4, 8, 12 and 16
description: The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16
time frame: Baseline, Week 1, 4, 8, 12 and 16
description: eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR
measure: Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16
time frame: Baseline, Week 12, and Week 16
description: Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.
measure: Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16
time frame: Baseline, Week 1, 4, 8, 12 and 16
description: Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.
measure: Change From Baseline in Serum Cystatin C at Weeks 12 and 16
time frame: Baseline, Week 12, and Week 16
description: Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.
measure: Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16
time frame: Baseline, Weeks 4, 8, 12 and 16
description: HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.
measure: Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12
time frame: 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16
time frame: Baseline, Weeks 1, 4, 8, 12 and 16
measure: Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16
time frame: Baseline, Weeks 1, 4, 8, 12 and 16
measure: Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16
time frame: Baseline, Weeks 1, 4, 8, 12 and 16
measure: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
time frame: Baseline up to Week 16 (follow-up visit)
description: The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
time frame: Baseline, Weeks 1, 4 and 12
description: Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after last study drug administration
description: An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.
measure: Number of Participants With Increased Fasting Blood Glucose
time frame: Baseline up to Week 16 (follow-up visit)
arm group label: Arm 1 PF-04634817
arm group type: Active Comparator
arm group label: Arm 2 Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-04634817
description: Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
arm group label: Arm 1 PF-04634817
intervention type: Drug
intervention name: Placebo
description: Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
arm group label: Arm 2 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Argentina
country: Australia
country: Canada
country: Germany
country: Hong Kong
country: Italy
country: Korea, Republic of
country: Malaysia
country: Peru
country: Poland
country: Puerto Rico
country: Romania
country: Spain
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1261007&StudyName=A%20Phase%202%20Multi-Center%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20A%20Chemokine%20CCR2/5%20Receptor%20Antagonist%20In%20Adults%20With%20Type%202%20D
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
mesh term: Diabetes Mellitus, Type 2
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 