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
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039987

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
Sponsors and Collaborators
University of Pittsburgh
Investigators
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 by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 29, 2014