Polycystic Kidney Disease Data Repository

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Rockefeller University
The Rogosin Institute
Memorial Sloan Kettering Cancer Center
New York Presbyterian Hospital
Temple University
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
First received: November 14, 2008
Last updated: May 4, 2015
Last verified: May 2015

November 14, 2008
May 4, 2015
November 2002
December 2016   (final data collection date for primary outcome measure)
Polycystic kidney disdease data repository [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Polycystic kidney disease data repository
Not Provided
Complete list of historical versions of study NCT00792155 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Polycystic Kidney Disease Data Repository
Autosomal Dominant Polycystic Kidney Disease Data Repository

Autosomal dominant polycystic kidney disease (PKD) is the most common inherited kidney disease, affecting more than 400,000 people in the U.S. and 5 million people worldwide. PKD is the 4th most common cause of kidney failure requiring dialysis and/or transplantation. Over half of all PKD patients develop kidney failure by age 60 years, although age of onset of kidney disease varies widely, even among members of the same family.

Despite the fact this is a relatively common problem, relatively few patients have been studied for a sufficient period of time to fully understand how patients are affected over the course of their lifetime. The reason for creating this repository is to collect information about PKD so that the investigators may fully understand its complications, including high blood pressure, heart attack, and stroke. This information may also aid in the development of improved treatment strategies.

Visit #1:

- An initial detailed history, physical examination, and laboratory evaluation

The following imaging procedures will be performed within three months of the first study visit:

  • Echocardiogram
  • Renal and hepatic magnetic resonance imaging

Additional assessment and testing:

  • Genetic assessment: An extensive family history of PKD will be obtained from the patient.
  • Genotyping of specific PKD1 and PKD2 mutations

Follow-up Study Visits:

- Patients will return to the outpatient facility for detailed follow-up examinations every other year after Visit 1.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA

whole blood

Non-Probability Sample

All patients enrolled in this study will have the diagnosis of autosomal dominant kidney disease. The diagnostic criteria for at-risk individuals (i.e., with a first degree family member with ADPKD) includes the presence of at least two(unilateral or bilateral) renal cysts, and two cysts in each kidney are considered sufficient for diagnosis in aged 15 to 29 years and in 30 to 59 years, respectively. In families of unknown genotype, the presence of three or more (unilateral or bilateral) renal cysts is sufficient for establishing the diagnosis in individuals aged 15 to 39 years, two or more cysts in each kidney is sufficient for individuals aged 40-59 years and four or more cysts in each kidney is required in individuals ≥60 years of age.

Polycystic Kidney Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate.

Exclusion Criteria:

  • Inability to provide informed consent.
18 Years and older
Contact: Stephanie Donahue, NP 212-746-1591 sld9001@nyp.org
Contact: Ines Chicos, CCRC 212-746-3541
United States
Rockefeller University
Rockefeller University
  • The Rogosin Institute
  • Memorial Sloan Kettering Cancer Center
  • New York Presbyterian Hospital
  • Temple University
Principal Investigator: Jon Blumenfeld, MD The Rogosin Institute
Principal Investigator: Stephanie Donahue, NP The Rogosin Institute
Rockefeller University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP