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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• ADPKD

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