UAB Recessive PKD Research and Translational Core Center

Autosomal Recessive Polycystic Kidney Disease Clinical Trial

— UAB RPKDCC  

Official title:

The ARPKD Clinical and Genetic Resource (UAB Recessive PKD Research and Translational Core Center)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00575705
• Other study ID #: P30DK074038
• Secondary ID: P30DK074038
• Status: Active, not recruiting
• Phase: N/A
• First received: December 13, 2007
• Last updated: March 15, 2011
• Start date: November 2005
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The University of Alabama at Birmingham Recessive Polycystic Kidney Disease Core Center (UAB RPKDCC) has established a NIDDK-funded, interdisciplinary center of excellence in PKD-related research, with specific emphasis on recessive PKD. Among the five Cores, the UAB RPKDCC includes the ARPKD Clinical and Genetic Resource, a Core resource designed to develop a unique set of clinical, genetic, and educational resources for ARPKD. The Core has three primary objectives:

1. To extend the observational study of ARPKD initiated by the North American ARPKD Database.

2. To provide a mechanism for genetic evaluation of patients with both classic ARPKD and unusual phenotypes of recessive PKD.

3. To develop educational tools for physicians and patients regarding the natural history, cause, development and effects of the disease, genetic testing, and clinical trials applicable to ARPKD.

Description:

The Study protocol and the Informed Consent for the Clinical Database will be posted on the website (http://www.arpkdstudies.uab.edu/) for review by potential participants and follow-up discussions with the PI and/or Research Nurse Coordinator. In addition, materials in paper format can be sent to interested potential participants upon request.

Two key elements will be required for patient enrollment: 1) certification that informed consent has been obtained, and 2) certification that permission for release of selected health information has also been obtained, including the date of signature. Once receipt of these items is confirmed, the following actions will proceed:

1. the participant will be assigned a unique identifier in the database and a clinician-specific web field will be opened for that identifier.

2. the participant/parents will confirm the name of their clinician to the database and notify their physician and/or genetic counselor (clinicians) of their intent to participate in this study.

3. the clinician will access the Physician Link on the website, type in the patient name and the referring center, and if matched to the patient's report, will receive the unique identifier for that patient. Once this is done, the name of the patient will be deleted from the online database and only the unique identifier will be used. Each clinician permitted to access this website will be tracked with a login procedure that includes a process to verify who is entering the system.

4. This unique identifier will allow the clinician to open the clinical database entry form and provide the information requested in each field. No names or initials will be collected in this data form, but gender and date of birth (which will be converted to age and only the month and year will be kept on file) will be requested.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 35 Years

Eligibility

Inclusion Criteria:

• Histopathology compatible with ARPKD based on renal biopsy or necropsy; or

• Sonographic evidence of diffusely enlarged, echogenic kidneys and at least one additional criteria:

1. patho-anatomical diagnosis in an affected sibling, or

2. absence of renal cysts in the ultrasound examination of both parents (studies would have been obtained as part of the evaluation of the affected child; parents must be > 30 yo), or

3. hepatic fibrosis based on either clinical or histopathologic evidence, or

4. parental consanguinity

Exclusion Criteria:

• ADPKD

• Urinary tract malformations

• Major congenital anomalies of other systems

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Autosomal Recessive Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Recessive

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

External Links

•   ARPKD Clinical and Genetic Resource (Core A of the UAB RPKDCC)