ADPKD Cohort Study
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.
Autosomal Dominant Polycystic Kidney Disease
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||84 Months|
|Official Title:||The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study|
- Change in GFR as compared to change in renal volume over time [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Differences in the ability to determine change in renal volume over time between MRI and ultrasound [ Time Frame: Three years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood, serum, urine, tissue
|Study Start Date:||June 1998|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02084849
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Arlene Chapman, MD||Emory University|