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ADPKD Cohort Study

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT02084849
Collaborator
PKD Foundation (Other)
624
Enrollment
1
Location
203
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if radiology tests of the kidneys as opposed to glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function) follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for progression to renal failure (dialysis or transplantation) have been identified and include those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene (the inherited abnormality responsible for the majority of PKD), men as opposed to women, those with episodes of visible blood or increased protein in their urine, and women who have experience more than three pregnancies. Individuals who are diagnosed with PKD in the first year of life or in utero (before birth) are also at high risk for progression to renal failure.

This study will also facilitate understanding of human diseases at the cellular and molecular level. We will be identifying genetic factors that may influence the severity of polycystic kidney disease (PKD). You are being asked to provide a sample of blood for the purpose of DNA or other biochemical analyses.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    624 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study
    Study Start Date :
    Jun 1, 1998
    Actual Primary Completion Date :
    May 1, 2015
    Actual Study Completion Date :
    May 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Group 1 will consist of 300 ADPKD individuals who are early in the course of their disease and demonstrate risk factors for progression to ESRD.
    Group 2

    Group 2 will consist of ADPKD subjects who have progressed to a more advanced stage of their renal disease. There is no limit with regard to the number of subjects to be recruited into this group.

    Outcome Measures

    Primary Outcome Measures

    1. Change in GFR as compared to change in renal volume over time [Three years]

    Secondary Outcome Measures

    1. Differences in the ability to determine change in renal volume over time between MRI and ultrasound [Three years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Group 1

    • Hypertension diagnosed early in the course of the disease (less than 25 years for men; less than 30 years for women)

    • ADPKD diagnosed in utero or in the first year of life

    • The presence of proteinuria (between 180 mg and 1 gm/day) without evidence of a second renal disorder

    • A history of more than 3 pregnancies and hypertension

    • A history of gross hematuria

    • A serum creatinine concentration less than 1.4 mg/dl

    • ADPKD diagnosed in childhood with more than 10 cysts

    Group 2

    • Serum creatinine concentration >1.4 and

    • Renal length greater than 15 cm and

    • Age less than 60 years of age

    • Severe pain or discomfort as assessed by the primary care physician related to ADPKD

    Exclusion Criteria:

    • Subjects, who in the assessment of the principal investigator cannot provide reliable follow-up

    • Subjects who cannot be exposed to iothalamate

    • Subjects who cannot undergo MRI due to the presence of a pacemaker or surgical clip in the abdomen

    • Subjects who are not anticipated to survive during the duration of the study (e.g. underlying malignancy)

    • Subjects who cannot provide informed consent

    • Women who are pregnant or who have undergone a pregnancy in the last 6 months or who are presently breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University
    • PKD Foundation

    Investigators

    • Principal Investigator: Arlene Chapman, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arlene Chapman, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT02084849
    Other Study ID Numbers:
    • IRB00041117
    • 0247-1998
    First Posted:
    Mar 12, 2014
    Last Update Posted:
    Jun 24, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Kidney Diseases
    Polycystic Kidney Diseases
    Polycystic Kidney, Autosomal Dominant

    Study Results

    No Results Posted as of Jun 24, 2015