<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/NCT02226341</url>
  </required_header>
  <id_info>
    <org_study_id>AAAN4752</org_study_id>
    <nct_id>NCT02226341</nct_id>
  </id_info>
  <brief_title>ACTHar in the Treatment of Lupus Nephritis</brief_title>
  <acronym>ACTHar</acronym>
  <official_title>Open-label Prospective Randomized Study to Determine the Efficacy and Safety of Two Dosing Regimens of ACTHar in the Treatment of Proliferative Lupus Nephritis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the&#xD;
      healthy cells and tissues, causing inflammation that can damage organs in the body. About 50%&#xD;
      of SLE patients experience inflammation in the kidneys. The purpose of this study is to&#xD;
      determine the effectiveness and safety of two dosing arms of ACTHar gel in treating&#xD;
      proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar&#xD;
      are safe and effective in treating proliferative LN (Class III and IV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic Lupus Erythematosus (SLE) is an autoimmune disease of unknown etiology that mainly&#xD;
      affects females of childbearing age. The disease is characterized by immune activation and&#xD;
      the development of autoantibodies.&#xD;
&#xD;
      About 50% of SLE patients experience inflammation of the kidneys. Lupus Nephritis (LN) is a&#xD;
      major cause of morbidity and mortality in patients with SLE. Mycophenolate Mofetil (MMF),&#xD;
      accompanied by Prednisone, is considered the current standard of care for LN. However,&#xD;
      long-term use of Prednisone has many serious side effects.&#xD;
&#xD;
      ACTHar Gel is an FDA approved drug comprised of an active substance called&#xD;
      adrenocorticotropic hormone (ACTH). ACTH belongs to an anti-inflammatory group called&#xD;
      melanocortins and carries out its effects by binding to five different melanocortin receptors&#xD;
      (MCRs). Specifically, ACTH binding to melanocortin 2 receptor subtype (MC2R) on the adrenal&#xD;
      cortex stimulates the production of cortisol that reduces inflammation in the kidney. In&#xD;
      addition to binding to melanocortin 1-5 receptor subtype (MC1-5R) and acting directly on&#xD;
      kidney tissues, ACTH may bind to MCRs on various cell types, such as immune cells, and&#xD;
      activate processes to protect the kidney.&#xD;
&#xD;
      This study will evaluate the most effective dose of ACTHar gel in proliferative LN (Class III&#xD;
      and IV) when given with MMF, the standard of care LN therapy. The intent of this study is to&#xD;
      determine the effectiveness and safety of ACTHar gel in an attempt to change the clinical&#xD;
      care requirements regarding steroid use in treating LN.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of patients with a complete response (CR)</measure>
    <time_frame>6 Months</time_frame>
    <description>Complete response (CR) is defined as all of the following criteria having been achieved:&#xD;
Stabilization of estimated glomerular filtration rate (eGFR) (i.e., a 6-month eGFR level ± 10% of baseline) or improvement if the screening value is changed from patient's baseline&#xD;
Inactive urinary sediment (red blood cells per high-power field [RBCs/HPF] &lt; 5-10, not due to gyn bleeding)&#xD;
Urine protein/creatinine ratio &lt; 0.5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent responders</measure>
    <time_frame>6 Months</time_frame>
    <description>Frequency of responders = CR + Partial Responders (PR). PR = improvement from baseline of at least ≥ 50% in all abnormal renal parameters (proteinuria and serum creatinine) without deterioration of any measurements at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of patients with extra-renal flares</measure>
    <time_frame>6 Months</time_frame>
    <description>Frequency of extra-renal flares as defined by the SELENA-SLEDAI Flare Index. Extra-renal disease activity measured by SELENA-SLEDAI and BILAG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean cortisol levels</measure>
    <time_frame>6 Months</time_frame>
    <description>Cortisol levels 8 hours after ACTHar dose in 2-3 patients per dosing arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of patients with steroid -like side effects</measure>
    <time_frame>6 Months</time_frame>
    <description>Steroid -like side effects: increase in blood pressure (BP) by 20 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), increased blood sugar with a fasting plasma glucose level ≥ 126 mg/dl, weight gain ≥ 10% of the initial weight, infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean urinary lymphocytes</measure>
    <time_frame>6 Months</time_frame>
    <description>Urinary markers of active inflammatory nephritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of patients with side effects</measure>
    <time_frame>6 Months</time_frame>
    <description>Side effects from taking ACTHar</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lupus Nephritis</condition>
  <arm_group>
    <arm_group_label>CellCept daily &amp; ACTHar gel biw</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated with CellCept 3 grams daily and ACTHar gel 80 U biw for 3 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CellCept daily &amp; ACTHar gel qod</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated with CellCept 3 grams daily for 3 months, and ACTHar gel 80 U qod for the first month and ACTHar gel 80 U biw for the following 2 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CellCept</intervention_name>
    <description>For both arms:&#xD;
CellCept 3 grams daily, oral, from Week 0-24 CellCept 2 grams daily, oral, from Week 25-144</description>
    <arm_group_label>CellCept daily &amp; ACTHar gel biw</arm_group_label>
    <arm_group_label>CellCept daily &amp; ACTHar gel qod</arm_group_label>
    <other_name>Mycophenolate Mofetil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACTHar gel</intervention_name>
    <description>Arm 1: 80 U biw, subcutaneous, for 3 months. Optionally additional 3 months of 80 U biw if a patient has partial response.</description>
    <arm_group_label>CellCept daily &amp; ACTHar gel biw</arm_group_label>
    <other_name>ACTHar</other_name>
    <other_name>H.P. ACTHar Gel</other_name>
    <other_name>Repository corticotropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACTHar gel</intervention_name>
    <description>Arm 2: 80 U qod, subcutaneous, for 1 month, then 80 U biw, subcutaneous, for 2 months. Optionally additional 3 months of 80 U biw if a patient has partial response.</description>
    <arm_group_label>CellCept daily &amp; ACTHar gel qod</arm_group_label>
    <other_name>ACTHar</other_name>
    <other_name>H.P. ACTHar Gel</other_name>
    <other_name>Repository corticotropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology&#xD;
             (ACR)/SLICC criteria&#xD;
&#xD;
          2. Age ≥ 16 years&#xD;
&#xD;
          3. Active lupus nephritis defined by:&#xD;
&#xD;
             a. Kidney biopsy documentation of International Society of Nephrology/Renal Pathology&#xD;
             Society (ISN/RPS) Class III or Class IV proliferative nephritis (including Class V&#xD;
             occurring in combination with Class III or IV) within 12 months and a urine&#xD;
             protein/creatinine ratio &gt;1 at time of entry to study&#xD;
&#xD;
          4. Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Moderately severe anemia (Hgb &lt; 8 mg/dL)&#xD;
&#xD;
          2. Neutropenia (&lt; 1,000/mm3)&#xD;
&#xD;
          3. Thrombocytopenia (platelets &lt; 50,000/mm3)&#xD;
&#xD;
          4. Positive purified protein derivative (PPD) test confirmed by positive Quantiferon TB&#xD;
             gold.&#xD;
&#xD;
          5. Pulmonary fibrotic changes on chest radiograph consistent with prior healed&#xD;
             tuberculosis&#xD;
&#xD;
          6. Active infections that in the opinion of the investigator increase the risks to the&#xD;
             subject.&#xD;
&#xD;
          7. Known human immunodeficiency virus (HIV) and hepatitis B or C&#xD;
&#xD;
          8. End-stage renal disease (estimated GFR clearance &lt; 20 mL/min/1.73 m2)&#xD;
&#xD;
          9. History of cancer, except carcinoma in situ and treated basal and squamous cell&#xD;
             carcinomas&#xD;
&#xD;
         10. Pregnancy&#xD;
&#xD;
         11. Lactation&#xD;
&#xD;
         12. Unwillingness to use a medically acceptable form of birth control (including but not&#xD;
             limited to a diaphragm, an intrauterine device, progesterone implants or injections,&#xD;
             oral contraceptives, the double-barrier method, or a condom)&#xD;
&#xD;
         13. Previous failure to respond to MMF&#xD;
&#xD;
         14. Use of rituximab within the past year&#xD;
&#xD;
         15. Use of experimental therapeutic agents within the past 60 days&#xD;
&#xD;
         16. Greater than or equal to 5 times the upper limit of normal of liver function tests&#xD;
             (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline&#xD;
             phosphatase)&#xD;
&#xD;
         17. Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal,&#xD;
             pulmonary, cardiac, or neurological disease (or, in the investigator's opinion, any&#xD;
             other concomitant medical condition that places the participant at risk by&#xD;
             participating in this study) with the exception of diseases or conditions related to&#xD;
             active SLE&#xD;
&#xD;
         18. Current substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anca D Askanase, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anca D Askanase, MD, MPH</last_name>
    <phone>212-305-0856</phone>
    <email>ada20@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel A Drolet, RN, MSN, AGNP-BC</last_name>
    <phone>212-342-1622</phone>
    <email>rad2145@cumc.columbia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University - Herbert Irving Pavilion</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pooja Mahadeshwar</last_name>
      <phone>212-342-9051</phone>
      <email>pm2844@cumc.columbia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Samantha C Nguyen</last_name>
      <phone>212-342-1587</phone>
      <email>scn2119@cumc.columbia.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rachel A Drolet, RN, MSN, AGNP-BC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anca D Askanase, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.rheumatologyatcolumbia.org/index-3.html</url>
    <description>CUMC Rheumatology Research Website</description>
  </link>
  <reference>
    <citation>Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.</citation>
    <PMID>11838846</PMID>
  </reference>
  <reference>
    <citation>Lam GK, Petri M. Assessment of systemic lupus erythematosus. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S120-32.</citation>
    <PMID>16273796</PMID>
  </reference>
  <reference>
    <citation>Austin HA 3rd, Muenz LR, Joyce KM, Antonovych TT, Balow JE. Diffuse proliferative lupus nephritis: identification of specific pathologic features affecting renal outcome. Kidney Int. 1984 Apr;25(4):689-95. doi: 10.1038/ki.1984.75.</citation>
    <PMID>6482173</PMID>
  </reference>
  <reference>
    <citation>Weening JJ, D'Agati VD, Schwartz MM, Seshan SV, Alpers CE, Appel GB, Balow JE, Bruijn JA, Cook T, Ferrario F, Fogo AB, Ginzler EM, Hebert L, Hill G, Hill P, Jennette JC, Kong NC, Lesavre P, Lockshin M, Looi LM, Makino H, Moura LA, Nagata M; International Society of Nephrology Working Group on the Classification of Lupus Nephritis; Renal Pathology Society Working Group on the Classification of Lupus Nephritis. The classification of glomerulonephritis in systemic lupus erythematosus revisited. Kidney Int. 2004 Feb;65(2):521-30. doi: 10.1111/j.1523-1755.2004.00443.x. Erratum In: Kidney Int. 2004 Mar;65(3):1132.</citation>
    <PMID>14717922</PMID>
  </reference>
  <reference>
    <citation>Bomback AS, Canetta PA, Beck LH Jr, Ayalon R, Radhakrishnan J, Appel GB. Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial. Am J Nephrol. 2012;36(1):58-67. doi: 10.1159/000339287. Epub 2012 Jun 19.</citation>
    <PMID>22722778</PMID>
  </reference>
  <reference>
    <citation>Schweitzer EJ, Yoon S, Fink J, Wiland A, Anderson L, Kuo PC, Lim JW, Johnson LB, Farney AC, Weir MR, Bartlett ST. Mycophenolate mofetil reduces the risk of acute rejection less in African-American than in Caucasian kidney recipients. Transplantation. 1998 Jan 27;65(2):242-8. doi: 10.1097/00007890-199801270-00017.</citation>
    <PMID>9458022</PMID>
  </reference>
  <reference>
    <citation>Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.</citation>
    <PMID>22087680</PMID>
  </reference>
  <reference>
    <citation>Belmont HM, Levartovsky D, Goel A, Amin A, Giorno R, Rediske J, Skovron ML, Abramson SB. Increased nitric oxide production accompanied by the up-regulation of inducible nitric oxide synthase in vascular endothelium from patients with systemic lupus erythematosus. Arthritis Rheum. 1997 Oct;40(10):1810-6. doi: 10.1002/art.1780401013.</citation>
    <PMID>9336415</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>March 17, 2016</last_update_submitted>
  <last_update_submitted_qc>March 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Anca Askanase</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Lupus</keyword>
  <keyword>Lupus Nephritis</keyword>
  <keyword>ACTHar</keyword>
  <keyword>Columbia</keyword>
  <keyword>Rheumatology</keyword>
  <keyword>CUMC</keyword>
  <keyword>Autoimmune</keyword>
  <keyword>SLE</keyword>
  <keyword>Proliferative Lupus Nephritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephritis</mesh_term>
    <mesh_term>Lupus Nephritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Adrenocorticotropic Hormone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02226341
org study id: AAAN4752
nct id: NCT02226341
lead sponsor: 
has dmc: Yes
Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the
      healthy cells and tissues, causing inflammation that can damage organs in the body. About 50%
      of SLE patients experience inflammation in the kidneys. The purpose of this study is to
      determine the effectiveness and safety of two dosing arms of ACTHar gel in treating
      proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar
      are safe and effective in treating proliferative LN (Class III and IV).
Systemic Lupus Erythematosus (SLE) is an autoimmune disease of unknown etiology that mainly
      affects females of childbearing age. The disease is characterized by immune activation and
      the development of autoantibodies.

      About 50% of SLE patients experience inflammation of the kidneys. Lupus Nephritis (LN) is a
      major cause of morbidity and mortality in patients with SLE. Mycophenolate Mofetil (MMF),
      accompanied by Prednisone, is considered the current standard of care for LN. However,
      long-term use of Prednisone has many serious side effects.

      ACTHar Gel is an FDA approved drug comprised of an active substance called
      adrenocorticotropic hormone (ACTH). ACTH belongs to an anti-inflammatory group called
      melanocortins and carries out its effects by binding to five different melanocortin receptors
      (MCRs). Specifically, ACTH binding to melanocortin 2 receptor subtype (MC2R) on the adrenal
      cortex stimulates the production of cortisol that reduces inflammation in the kidney. In
      addition to binding to melanocortin 1-5 receptor subtype (MC1-5R) and acting directly on
      kidney tissues, ACTH may bind to MCRs on various cell types, such as immune cells, and
      activate processes to protect the kidney.

      This study will evaluate the most effective dose of ACTHar gel in proliferative LN (Class III
      and IV) when given with MMF, the standard of care LN therapy. The intent of this study is to
      determine the effectiveness and safety of ACTHar gel in an attempt to change the clinical
      care requirements regarding steroid use in treating LN.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of patients with a complete response (CR)
time frame: 6 Months
description: Complete response (CR) is defined as all of the following criteria having been achieved:
Stabilization of estimated glomerular filtration rate (eGFR) (i.e., a 6-month eGFR level ± 10% of baseline) or improvement if the screening value is changed from patient's baseline
Inactive urinary sediment (red blood cells per high-power field [RBCs/HPF] < 5-10, not due to gyn bleeding)
Urine protein/creatinine ratio < 0.5
measure: Percent responders
time frame: 6 Months
description: Frequency of responders = CR + Partial Responders (PR). PR = improvement from baseline of at least ≥ 50% in all abnormal renal parameters (proteinuria and serum creatinine) without deterioration of any measurements at 6 months
measure: Percent of patients with extra-renal flares
time frame: 6 Months
description: Frequency of extra-renal flares as defined by the SELENA-SLEDAI Flare Index. Extra-renal disease activity measured by SELENA-SLEDAI and BILAG
measure: Mean cortisol levels
time frame: 6 Months
description: Cortisol levels 8 hours after ACTHar dose in 2-3 patients per dosing arm
measure: Percent of patients with steroid -like side effects
time frame: 6 Months
description: Steroid -like side effects: increase in blood pressure (BP) by 20 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), increased blood sugar with a fasting plasma glucose level ≥ 126 mg/dl, weight gain ≥ 10% of the initial weight, infections
measure: Mean urinary lymphocytes
time frame: 6 Months
description: Urinary markers of active inflammatory nephritis
measure: Percent of patients with side effects
time frame: 6 Months
description: Side effects from taking ACTHar
arm group label: CellCept daily & ACTHar gel biw
arm group type: Active Comparator
description: Patients will be treated with CellCept 3 grams daily and ACTHar gel 80 U biw for 3 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
arm group label: CellCept daily & ACTHar gel qod
arm group type: Active Comparator
description: Patients will be treated with CellCept 3 grams daily for 3 months, and ACTHar gel 80 U qod for the first month and ACTHar gel 80 U biw for the following 2 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
intervention type: Drug
intervention name: CellCept
description: For both arms:
CellCept 3 grams daily, oral, from Week 0-24 CellCept 2 grams daily, oral, from Week 25-144
arm group label: CellCept daily & ACTHar gel biw
arm group label: CellCept daily & ACTHar gel qod
other name: Mycophenolate Mofetil
intervention type: Drug
intervention name: ACTHar gel
description: Arm 1: 80 U biw, subcutaneous, for 3 months. Optionally additional 3 months of 80 U biw if a patient has partial response.
arm group label: CellCept daily & ACTHar gel biw
other name: ACTHar
other name: H.P. ACTHar Gel
other name: Repository corticotropin
intervention type: Drug
intervention name: ACTHar gel
description: Arm 2: 80 U qod, subcutaneous, for 1 month, then 80 U biw, subcutaneous, for 2 months. Optionally additional 3 months of 80 U biw if a patient has partial response.
arm group label: CellCept daily & ACTHar gel qod
other name: ACTHar
other name: H.P. ACTHar Gel
other name: Repository corticotropin
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Anca D Askanase, MD, MPH
role: Principal Investigator
affiliation: Columbia University
last name: Anca D Askanase, MD, MPH
phone: 212-305-0856
email: ada20@cumc.columbia.edu
last name: Rachel A Drolet, RN, MSN, AGNP-BC
phone: 212-342-1622
email: rad2145@cumc.columbia.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
url: http://www.rheumatologyatcolumbia.org/index-3.html
description: CUMC Rheumatology Research Website
citation: Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PMID: 11838846
citation: Lam GK, Petri M. Assessment of systemic lupus erythematosus. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S120-32.
PMID: 16273796
citation: Austin HA 3rd, Muenz LR, Joyce KM, Antonovych TT, Balow JE. Diffuse proliferative lupus nephritis: identification of specific pathologic features affecting renal outcome. Kidney Int. 1984 Apr;25(4):689-95. doi: 10.1038/ki.1984.75.
PMID: 6482173
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responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Anca Askanase
investigator title: Associate Professor of Medicine
mesh term: Nephritis
mesh term: Lupus Nephritis
mesh term: Mycophenolic Acid
mesh term: Adrenocorticotropic Hormone