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Polycystic Kidney Disease Data Repository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00792155
Recruitment Status : Recruiting
First Posted : November 17, 2008
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
Weill Medical College of Cornell University
New York Presbyterian Hospital
Information provided by (Responsible Party):
The Rogosin Institute

Tracking Information
First Submitted Date November 14, 2008
First Posted Date November 17, 2008
Last Update Posted Date April 13, 2020
Study Start Date November 2002
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2012)
Polycystic kidney disdease data repository [ Time Frame: 10 years ]
Polycystic kidney disease data repository
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Polycystic Kidney Disease Data Repository
Official Title Autosomal Dominant Polycystic Kidney Disease Data Repository
Brief 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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population All patients enrolled in this study will have the diagnosis of autosomal dominant kidney disease. The diagnostic criteria for at-risk individuals (i.e., with a first degree family member with ADPKD) includes the presence of at least two(unilateral or bilateral) renal cysts, and two cysts in each kidney are considered sufficient for diagnosis in aged 15 to 29 years and in 30 to 59 years, respectively. In families of unknown genotype, the presence of three or more (unilateral or bilateral) renal cysts is sufficient for establishing the diagnosis in individuals aged 15 to 39 years, two or more cysts in each kidney is sufficient for individuals aged 40-59 years and four or more cysts in each kidney is required in individuals ≥60 years of age.
Condition Polycystic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 5, 2015)
500
Original Enrollment Not Provided
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate.

Exclusion Criteria:

  • Inability to provide informed consent.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ines Chicos, MS, CCRC 212-746-3541 inc9012@nyp.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00792155
Other Study ID Numbers 0304006105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The Rogosin Institute
Study Sponsor The Rogosin Institute
Collaborators
  • Weill Medical College of Cornell University
  • New York Presbyterian Hospital
Investigators
Principal Investigator: Jon Blumenfeld, MD The Rogosin Institute
PRS Account The Rogosin Institute
Verification Date April 2020