Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease

NCT01039987 | Completed

• 1 other identifier: DK056961
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 5

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal dominant polycystic kidney disease; ADPKD; kidney; Biomarker; MRI

Outcome Measures

Primary Outcomes (1)

• kidney volume

  three years

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (5)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Mayo Clinic

Rochester, Minnesota, 559005, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 23520042 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Marva Moxey-Mims, M.D.

  NIH, NIDDK, DKUH

  STUDY DIRECTOR

• K. Ty BAE, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology and Bioengineering

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: September 1, 1999
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

US (5)