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)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • University of Manitoba Health Sciences Centre
    • Winnipeg, Manitoba, Canada
      • Children's Hospital of Winnipeg
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation, Glickman Urological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Clinical Trials in Organ Transplantation
• Investigators: Study Chair: Donald E Hricik, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Clinical Trials in Organ Transplantation (CTOT)

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 3, 2013

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Rejection; Transplant; Kidney
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: DAIT CTOT-17

Plan for Individual participant data (IPD)

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: SDY1094
   Information comments: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. Data analysis tools are also available to researchers.
2. Study Protocol
   Information identifier: SDY1094
   Information comments: ImmPort study identifier is SDY1094.
3. Study summary, -design, -summary of participant assessments, -interventions, -medications, -demographics, -lab tests, -study files et al.
   Information identifier: SDY1094
   Information comments: ImmPort study identifier is SDY1094.