Clinical trial NCT01974999: A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study
Official title: A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease
Kidney Failure
End Stage Renal Disease
Keywords: Kidney
Transplant
Rejection
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation
First posted: 2013-11-03
Enrollment: 184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was selected based on their previous participation in the parent study (CTOT-01). A total of 280 subjects were enrolled and transplanted in the Clinical Trials in Organ Transplantation

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.


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.

Primary outcomes:
measure: Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation
timeFrame: Day 1
Secondary outcomes:
measure: Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant
timeFrame: Day 1
measure: Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant
timeFrame: Day 1
measure: Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant
timeFrame: Day 1
measure: Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant
timeFrame: Day 1
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, Glickman Urological Institute
state: Ohio
city: Winnipeg
country: Canada
facility: University of Manitoba Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Children's Hospital of Winnipeg
state: Manitoba
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Peter S Heeger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Donald E Hricik, MD
role: STUDY_CHAIR
References:
citation: Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS; CTOT-17 consortium. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17. Transplantation. 2018 Apr;102(4):673-680. doi: 10.1097/TP.0000000000002026.