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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01974999

Enrollment

184

Registered

2013-11-04

Start date

2013-10-31

Completion date

2014-07-31

Last updated

2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Kidney Disease, Kidney Failure

Keywords

Kidney, Transplant, Rejection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant	Day 1
Change in Chronic Kidney Disease stages between transplant and 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

Countries

Canada, United States

Outcome results