Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease

NCT ID: NCT01039987

Last Updated: 2017-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

211 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Kyongtae Ty Bae, M.D., Ph.D.

Professor of Radiology and Bioengineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marva Moxey-Mims, M.D.

Role: STUDY_DIRECTOR

NIH, NIDDK, DKUH

K. Ty BAE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Alabama-Birmingham

Birmingham, Alabama, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Kansas

Kansas City, Kansas, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23520042 (View on PubMed)

Other Identifiers

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DK056961

Identifier Type: -

Identifier Source: org_study_id

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