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

NCT01974999 | Completed DMC

• 1 other identifier: DAIT CTOT-17
• Study Type: observational
• Target: 184
• Locations: 2 countries
• Sites: 7

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.

Conditions

Kidney Disease; Kidney Failure; End Stage Renal Disease

Keywords

Kidney; Transplant; Rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Clinical Trials in Organ Transplantation: collaborator

Study Sites (7)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation, Glickman Urological Institute

Cleveland, Ohio, 44195, United States

Location

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

• 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.

  PMID: 29189482 RESULT

Related Links

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

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic; Rejection, Psychology

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Peter S Heeger, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Donald E Hricik, MD

  University Hospitals Cleveland Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 3, 2019

Record last verified: 2018-12

Locations

CA (2); US (5)