Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP II)
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Purpose
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.
| Condition |
|---|
|
Autosomal Dominant Polycystic Kidney Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II |
- kidney volume [ Time Frame: three years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood, urine
| Estimated Enrollment: | 211 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | December 2010 |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants who are diagnosed with ADPKD between the ages of 15 and 45 with risk factors (2/3 of the study population) or without risk factors (1/3 of the study population)for progression to ESRD with relatively normal renal function were be eligible for recruitment into the CRISP I study. The objective of the recruitment process was to identify ADPKD participants with the appropriate level of renal function who are either at high or low risk for progression to ESRD, who will be available for the entire follow-up period and who are likely to be compliant with the study protocols and visit schedules.
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:
- 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;
- Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study;
- Inability to provide written informed consent
Contacts and Locations| United States, Alabama | |
| University of Alabama-Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Kansas | |
| University of Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 559005 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Study Director: | Marva Moxey-Mims, M.D. | NIH, NIDDK, DKUH |
| Principal Investigator: | K. Ty BAE, MD, PhD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Kyongtae T. Bae, M.D. Ph.D., University of Pittsburgh, Pittsburgh, Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01039987 History of Changes |
| Other Study ID Numbers: | DK056961 |
| Study First Received: | December 23, 2009 |
| Last Updated: | December 24, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Autosomal dominant polycystic kidney disease ADPKD kidney Biomarker MRI |
Additional relevant MeSH terms:
|
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Kidney Diseases, Cystic |
ClinicalTrials.gov processed this record on June 13, 2013