A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

Completed

Conditions studied: Kidney Disease, Kidney Failure, End Stage Renal Disease

In brief

This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.

Key facts

Study ID

NCT01974999

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

184

Starts

2013-10-01

Expected to finish

2014-07-01

Last updated by the study team

2019-01-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants previously enrolled in the CTOT-01 study.
• Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.

You may not qualify if…

• Withdrawal of consent to continue in the CTOT-01 study.

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic Foundation, Glickman Urological Institute — Cleveland, Ohio, United States
• University of Manitoba Health Sciences Centre — Winnipeg, Manitoba, Canada
• Children's Hospital of Winnipeg — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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