A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)

National Institute of Allergy and Infectious Diseases (NIAID)7 sites in 2 countries184 target enrollmentOctober 2013

ConditionsKidney Disease Kidney Failure End Stage Renal Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Disease
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment: 184
Locations: 7
Primary Endpoint: Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

July 2014

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation

Time Frame: Day 1

Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort

Secondary Outcomes

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)