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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01039987
First received: December 23, 2009
Last updated: December 24, 2009
Last verified: December 2009

December 23, 2009
December 24, 2009
September 1999
Not Provided
kidney volume [ Time Frame: three years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01039987 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood, urine

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.

Autosomal Dominant Polycystic Kidney Disease
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Bae K, Park B, Sun H, Wang J, Tao C, Chapman AB, Torres VE, Grantham JJ, Mrug M, Bennett WM, Flessner MF, Landsittel DP, Bae KT; Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP). Segmentation of individual renal cysts from MR images in patients with autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2013 Jul;8(7):1089-97. doi: 10.2215/CJN.10561012. Epub 2013 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
211
December 2010
Not Provided

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
Both
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01039987
DK056961
No
Kyongtae T. Bae, M.D. Ph.D., University of Pittsburgh, Pittsburgh, Pennsylvania
University of Pittsburgh
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Marva Moxey-Mims, M.D. NIH, NIDDK, DKUH
Principal Investigator: K. Ty BAE, MD, PhD University of Pittsburgh
University of Pittsburgh
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP