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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01974999
First received: October 28, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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
Kidney Disease
Kidney Failure
End Stage Renal Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change in estimated glomerular filtration Rate (eGFR) from 6 months to 5 years post-transplantation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Modification of Diet in Renal Disease (MDRD) in the adult cohort and Schwartz method in the pediatric cohort


Secondary Outcome Measures:
  • Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 243
Study Start Date: October 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974999

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States
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
Cleveland Clinic Foundation, Glickman Urological Institute
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Canada, Manitoba
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
Clinical Trials in Organ Transplantation
Investigators
Principal Investigator: Peter S Heeger, MD Mount Sinai School of Medicine
Study Chair: Donald E Hricik, MD University Hospitals of Cleveland
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01974999     History of Changes
Other Study ID Numbers: DAIT CTOT-17
Study First Received: October 28, 2013
Last Updated: May 29, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014