Polycystic Kidney Disease Data Repository
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Purpose
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.
| Condition |
|---|
|
Polycystic Kidney Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Autosomal Dominant Polycystic Kidney Disease Data Repository |
- Polycystic kidney disdease data repository [ Time Frame: 10 years ] [ Designated as safety issue: No ]Polycystic kidney disease data repository
Biospecimen Retention: Samples With DNA
whole blood
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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:
- Echocardiogram
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Any person, age 18 or older, with previously diagnosed ADPKD is eligible to participate.
Exclusion Criteria:
- Inability to provide informed consent.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00792155
| Contact: Stephanie Donahue, NP | 212-746-1591 | sld9001@nyp.org | |
| Contact: Ines Chicos, CCRC | 212-746-3541 |
| United States, New York | |
| The Rockefeller University Hospital | Recruiting |
| New York, New York, United States, 10065 | |
| Contact 800-782-2737 | |
| The Rogosin Institute | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Stephanie Donahue, NP 212-746-1591 sld9001@nyp.org | |
| Principal Investigator: | Jon Blumenfeld, MD | The Rogosin Institute | |
| Principal Investigator: | Stephanie Donahue, NP | The Rogosin Institute |
More Information
No publications provided
| Responsible Party: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00792155 History of Changes |
| Other Study ID Numbers: | JBL-0496 |
| Study First Received: | November 14, 2008 |
| Last Updated: | November 3, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rockefeller University:
|
PKD |
Additional relevant MeSH terms:
|
Kidney Diseases Multicystic Dysplastic Kidney Polycystic Kidney Diseases Congenital Abnormalities |
Kidney Diseases, Cystic Urogenital Abnormalities Urologic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015