Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease

• Registration Number: NCT01039987
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
kidney volume	three years

Trial Locations

Locations (5)

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Kansas; 🇺🇸 Kansas City, Kansas, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States