Polycystic Kidney Disease Data Repository

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: November 3, 2014
Last verified: December 2013

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.

Polycystic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autosomal Dominant Polycystic Kidney Disease Data Repository

Resource links provided by NLM:

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Polycystic kidney disdease data repository [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Polycystic kidney disease data repository

Biospecimen Retention:   Samples With DNA

whole blood

Estimated Enrollment: 300
Study Start Date: November 2002
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.


Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792155

Contact: Stephanie Donahue, NP 212-746-1591 sld9001@nyp.org
Contact: Ines Chicos, CCRC 212-746-3541

United States, New York
The Rockefeller University Hospital Recruiting
New York, New York, United States, 10065
Contact    800-782-2737      
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Stephanie Donahue, NP    212-746-1591    sld9001@nyp.org   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00792155     History of Changes
Other Study ID Numbers: JBL-0496
Study First Received: November 14, 2008
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on March 26, 2015