Repository Study of Autosomal Dominant Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

— Repository  

Official title:

Repository Study of Autosomal Dominant Polycystic Kidney Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01988038
• Other study ID #: 1305013979
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2013
• Last updated: March 27, 2017
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females

• Age 18 years and older

• Previously diagnosed with ADPKD

Exclusion Criteria:

• Inability to provide informed consent

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
The Rogosin Institute	New York Presbyterian Hospital, 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 Autosomal Dominant Polycystic Kidney Disease (ADPKD) progression	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.	Up to 20 years