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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01039987
Other study ID # DK056961
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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