- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00792155
Polycystic Kidney Disease Data Repository
Autosomal Dominant Polycystic Kidney Disease Data Repository
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.
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jon Blumenfeld, MD
- Phone Number: 212-746-1495
- Email: jdblume@nyp.org
Study Locations
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New York
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New York, New York, United States, 10021
- Recruiting
- The Rogosin Institute
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Contact:
- Jon Blumenfeld, MD
- Phone Number: 212-746-1495
- Email: jdblume@nyp.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate.
Exclusion Criteria:
- Inability to provide informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polycystic kidney disdease data repository
Time Frame: 10 years
|
Polycystic kidney disease data repository
|
10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon Blumenfeld, MD, The Rogosin Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0304006105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycystic Kidney Disease
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University of North Carolina, Chapel HillNational Institute of General Medical Sciences (NIGMS)CompletedRenal Disease | Autosomal Dominant Polycystic Kidney Disease | ADPKDUnited States
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Palladio BiosciencesCentessa Pharmaceuticals plcTerminatedADPKD | Polycystic Kidney Disease, AdultUnited States
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Emory UniversityPKD FoundationCompleted
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Mario Negri Institute for Pharmacological ResearchOtsuka Pharmaceutical Italy S.r.l.CompletedAutosomal Dominant Polycystic Kidney DiseaseItaly
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Mayo ClinicUniversity of Kansas Medical CenterCompletedAutosomal Dominant Polycystic Kidney DiseaseUnited States
-
CHU de ReimsCompletedAutosomal Dominant Polycystic Kidney DiseaseFrance
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Otsuka Pharmaceutical Development & Commercialization...CompletedAutosomal Dominant Polycystic Kidney DiseaseUnited States
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Regional Hospital HolstebroAarhus University HospitalCompletedAutosomal Dominant Polycystic Kidney DiseaseDenmark
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University Hospital, BrestUnknownAutosomal Dominant Polycystic Kidney DiseaseFrance