<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/NCT01722383</url>
  </required_header>
  <id_info>
    <org_study_id>RRK3917</org_study_id>
    <nct_id>NCT01722383</nct_id>
  </id_info>
  <brief_title>What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study</brief_title>
  <acronym>RIISC</acronym>
  <official_title>What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Birmingham NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Birmingham NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with&#xD;
      significant morbidity and mortality. People at highest risk from progressive CKD are defined&#xD;
      by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of&#xD;
      significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of&#xD;
      this group will enable improved risk stratification and direct the development of better&#xD;
      targeted management for people with CKD. To address these requirements we have established&#xD;
      the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients&#xD;
      at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical&#xD;
      phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants not alive</measure>
    <time_frame>up to 10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who reach End Stage Kidney Disease</measure>
    <time_frame>up to 10 years</time_frame>
    <description>End Stage Kidney Disease describes a requirement for chronic dialysis treatment or a kidney transplant</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants who sustain one or more cardiovascular events</measure>
    <time_frame>up to 10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients who require hospitalisation</measure>
    <time_frame>up to 10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients who sustain a decline of kidney function</measure>
    <time_frame>up to 10 years</time_frame>
    <description>As measured by estimated glomerular filtration rate</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">932</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Chronic kidney disease</arm_group_label>
    <description>Stages 3-5 chronic kidney disease (pre-dialysis)</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, Plasma, Urine, DNA, Saliva, Dental Plaque&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Secondary care kidney disease clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Decline of eGFR of ≥5mls/min/year or ≥10mls/min/5years&#xD;
&#xD;
          -  and/or urinary albumin-creatinine ration (ACR) ≥70 mg/mmol on three occasions&#xD;
&#xD;
          -  and/or CKD 4 or 5 (pre-dialysis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  renal replacement therapy&#xD;
&#xD;
          -  immunosuppression&#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>Paul Cockwell, MB BCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>October 4, 2016</last_update_submitted>
  <last_update_submitted_qc>October 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Birmingham NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Paul Cockwell</investigator_full_name>
    <investigator_title>Consultant Nephrologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymised patient data is being shared within the remit of the ethics for this study with collaborators</ipd_description>
  </patient_data>
  <!-- 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/NCT01722383
org study id: RRK3917
nct id: NCT01722383
lead sponsor: 
has dmc: No
Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with
      significant morbidity and mortality. People at highest risk from progressive CKD are defined
      by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of
      significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of
      this group will enable improved risk stratification and direct the development of better
      targeted management for people with CKD. To address these requirements we have established
      the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients
      at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical
      phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent
      follow-up.
observational model: Cohort
time perspective: Prospective
measure: Number of participants not alive
time frame: up to 10 years
measure: Number of participants who reach End Stage Kidney Disease
time frame: up to 10 years
description: End Stage Kidney Disease describes a requirement for chronic dialysis treatment or a kidney transplant
measure: Number of participants who sustain one or more cardiovascular events
time frame: up to 10 years
measure: Number of patients who require hospitalisation
time frame: up to 10 years
measure: Number of patients who sustain a decline of kidney function
time frame: up to 10 years
description: As measured by estimated glomerular filtration rate
arm group label: Chronic kidney disease
description: Stages 3-5 chronic kidney disease (pre-dialysis)
Serum, Plasma, Urine, DNA, Saliva, Dental Plaque
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Cockwell, MB BCh
role: Principal Investigator
affiliation: University Hospital Birmingham
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University Hospital Birmingham NHS Foundation Trust
investigator full name: Paul Cockwell
investigator title: Consultant Nephrologist
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Yes
ipd description: Anonymised patient data is being shared within the remit of the ethics for this study with collaborators