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

• ClinicalTrials.gov Identifier: NCT01974999
• Recruitment Status: Completed
• First Posted: November 3, 2013
• Last Update Posted: January 3, 2019
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Clinical Trials in Organ Transplantation
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

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.

Condition or disease
Kidney Disease; Kidney Failure; End Stage Renal Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 184 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)
• Study Start Date: October 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant [ Time Frame: Day 1 ]
2. Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant [ Time Frame: Day 1 ]
3. Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant [ Time Frame: Day 1 ]
4. Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant [ Time Frame: Day 1 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

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.

Contacts and Locations

Locations

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, New York

Mount Sinai School of Medicine

New York, New York, United States, 10029

United States, Ohio

University Hospitals of Cleveland

Cleveland, Ohio, United States, 44106

Cleveland Clinic Foundation, Glickman Urological Institute

Cleveland, Ohio, United States, 44195

Canada, Manitoba

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 1R9

Children's Hospital of Winnipeg

Winnipeg, Manitoba, Canada

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Clinical Trials in Organ Transplantation

Investigators

• Principal Investigator: Peter S Heeger, MD; Icahn School of Medicine at Mount Sinai
• Study Chair: Donald E Hricik, MD; University Hospitals Cleveland Medical Center

More Information

Additional Information:

National Institute of Allergy and Infectious Diseases (NIAID) 

Division of Allergy, Immunology, and Transplantation (DAIT) 

Clinical Trials in Organ Transplantation (CTOT) 

Study Data/Documents: Individual Participant Data Set 

Identifier: SDY1094
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.

Study Protocol 

Identifier: SDY1094
ImmPort study identifier is SDY1094.

Study summary, -design, -summary of participant assessments, -interventions, -medications, -demographics, -lab tests, -study files et al. 

Identifier: SDY1094
ImmPort study identifier is SDY1094.

Publications of Results:

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.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT01974999
• Other Study ID Numbers: DAIT CTOT-17
• First Posted: November 3, 2013
• Last Update Posted: January 3, 2019
• Last Verified: December 2018

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Kidney; Transplant; Rejection

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Urologic Diseases; Renal Insufficiency, Chronic