Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

— CRISP II  

Official title:

Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039987
• Other study ID #: DK056961
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: August 14, 2017
• Start date: September 1999
• Est. completion date: March 2011

Study information

• Verified date: August 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease.

The awarded participating clinical centers are Emory University, University of Kansas, and Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington University to the University of Pittsburgh, the DCIAC for CRISP II is located at the University of Pittsburgh.

Description:

The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

1. CRISP I participants will be invited to participate in CRISP II. At entry into CRISP I participants met a number of inclusion and exclusion criteria.

Exclusion Criteria:

1. Current psychiatric or addiction or non-compliance disorder that in the discretion of the principal investigator indicates that the subject will not successfully complete the study;

2. Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study;

3. Inability to provide written informed consent

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	University of Kansas	Kansas City	Kansas
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kidney volume		three years