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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00792155
Other study ID # 0304006105
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2002
Est. completion date December 2026

Study information

Verified date October 2023
Source The Rogosin Institute
Contact Jon Blumenfeld, MD
Phone 212-746-1495
Email jdblume@nyp.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate. Exclusion Criteria: - Inability to provide informed consent.

Study Design


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 Polycystic kidney disdease data repository Polycystic kidney disease data repository 10 years
See also
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Completed NCT02166489 - Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease Phase 1
Recruiting NCT01873235 - PKD Clinical and Translational Core Study
Recruiting NCT06325644 - Well-Formulated Ketogenic Diet Polycystic Kidney Disease N/A
Completed NCT02697617 - Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease Phase 2
Completed NCT02142101 - Evaluation of Gut Bacteria in Patients With Polycystic Kidney Disease N/A
Recruiting NCT02936791 - Early PKD Observational Cohort Study