Repository Study of Autosomal Dominant Polycystic Kidney Disease

Withdrawn

• Conditions: Autosomal Dominant Polycystic Kidney Disease

• Registration Number: NCT01988038
• Lead Sponsor: The Rogosin Institute

Brief Summary

The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD Repository has been designed to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of the disorder and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including renal failure, cardiovascular disease, and stroke.

Detailed Description

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Males and females
• Age 18 years and older
• Previously diagnosed with ADPKD

Exclusion Criteria

• Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Natural history of Autosomal Dominant Polycystic Kidney Disease (ADPKD) progression	Up to 20 years	The primary interest of this protocol is to characterize the renal and extrarenal manifestations of ADPKD, evaluate the natural history of the disease progression, and explore potential associations between PKD gene variants and ADPKD phenotype.

Trial Locations

Locations (1)

The Rogosin Institute; 🇺🇸 New York, New York, United States