Polycystic Kidney Disease Data Repository

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Polycystic Kidney Disease

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:

- 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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Autosomal Dominant Polycystic Kidney Disease Data Repository
Study Start Date :	November 2002
Estimated Primary Completion Date :	December 2026
Estimated Study Completion Date :	December 2026

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Polycystic kidney disdease data repository [ Time Frame: 10 years ]
   Polycystic kidney disease data repository

Biospecimen Retention:   Samples With DNA

whole blood

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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.

Criteria

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

United States, New York
The Rogosin Institute	Recruiting
New York, New York, United States, 10021
Contact: Stephanie Donahue, NP 212-746-1591 sld9001@nyp.org

Sponsors and Collaborators

The Rogosin Institute

Weill Medical College of Cornell University

New York Presbyterian Hospital

Investigators

Principal Investigator:	Jon Blumenfeld, MD	The Rogosin Institute

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	The Rogosin Institute
ClinicalTrials.gov Identifier:	NCT00792155 History of Changes
Other Study ID Numbers:	0304006105
First Posted:	November 17, 2008
Last Update Posted:	April 10, 2018
Last Verified:	April 2018

Keywords provided by The Rogosin Institute:

PKD

Additional relevant MeSH terms:

Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Urologic Diseases	Kidney Diseases, Cystic; Abnormalities, Multiple; Congenital Abnormalities; Genetic Diseases, Inborn