Clinical trial NCT01988038: Repository Study of Autosomal Dominant Polycystic Kidney Disease
Official title: Repository Study of Autosomal Dominant Polycystic Kidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease
Disease Progression
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: New York Presbyterian Hospital
First posted: 2013-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled in this study will have the diagnosis of autosomal dominant polycystic kidney disease (ADPKD). 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 one or more (unilateral or bilateral) renal cysts is sufficient for establishing the diagnosis in individuals aged 15 to 29 years, two or more cysts in each kidney is sufficient for individuals aged 30-49 years.

Brief summary: The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD Repository has been designed to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of the disorder and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including renal failure, cardiovascular disease, and stroke.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age 18 years and older
* Previously diagnosed with ADPKD

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Natural history of Autosomal Dominant Polycystic Kidney Disease (ADPKD) progression
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Jon Blumenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: