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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01039987
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : August 17, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Autosomal Dominant Polycystic Kidney Disease

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 Design

Study Type : Observational
Actual Enrollment : 211 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II
Study Start Date : September 1999
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. kidney volume [ Time Frame: three years ]

Biospecimen Retention:   Samples With DNA
blood, urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039987

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
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyongtae Ty Bae, M.D., Ph.D., Professor of Radiology and Bioengineering, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01039987     History of Changes
Other Study ID Numbers: DK056961
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Kyongtae Ty Bae, M.D., Ph.D., University of Pittsburgh:
Autosomal dominant polycystic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn