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

Completed

• Conditions: Kidney Disease; Kidney Failure; End Stage Renal Disease

• Registration Number: NCT01974999
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-31
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation	Day 1	Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort

Secondary Outcome Measures

Name	Time	Method
Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant	Day 1
Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant	Day 1
Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant	Day 1
Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant	Day 1

Trial Locations

Locations (7)

University of Manitoba Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada

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

Cleveland Clinic Foundation, Glickman Urological Institute; 🇺🇸 Cleveland, Ohio, United States

Children's Hospital of Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States