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NCT02161068 Clinical Trial

Clinical Care of Autosomal Polycystic Kidney Disease: Retrospective Analysis and Prospective PKD Genotyping

ADPKD Clinical Trial

— ADPKD  

Official title:
Chart Review/PKD Genotyping

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02161068
Other study ID # 1308014251
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2013
Est. completion date November 1, 2021

Study information
Verified date February 2022
Source The Rogosin Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective analysis to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of ADPKD and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular disease.

Description:

To explore questions regarding the natural history of PKD, as well as other, unforeseen issues, a comprehensive database of demographic, clinical, biochemical, and genetic data is required. This descriptive retrospective study can serve as a source of information regarding either the entire ADPKD population, or subsets of patients with specifically targeted characteristics. This will inform future prospective studies that will be designed to address issues regarding the natural history and complications of ADPKD. The goal of this project is to collect data from a large population of patients with PKD. Based upon the estimated prevalence of PKD (1:500 and 1:1000 live births), it is estimated that there may be 10,000 PKD patients in the New York City area. This sample size far exceeds any database established thus far. As many as 40% of affected PKD patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). Furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects should have a confirmed ADPKD diagnosis. Exclusion Criteria: - Unable to provide informed consent for PKD Genotyping.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Rogosin Institute New York New York

Sponsors (2)
Lead Sponsor Collaborator
The Rogosin Institute Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Natural history of ADPKD Retrospective review to determine clinical, genetic, and radiographic characteristics that may influence the incidence of renal and extrarenal complications of ADPKD and prospective PKD genotyping if not previously performed. Up to 11 years
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