A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study
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|ClinicalTrials.gov Identifier: NCT01974999|
Recruitment Status : Completed
First Posted : November 3, 2013
Last Update Posted : January 3, 2019
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|Condition or disease|
|Kidney Disease Kidney Failure End Stage Renal Disease|
|Study Type :||Observational|
|Actual Enrollment :||184 participants|
|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|
- 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
- Patient survival as assessed by the incidence of death reported in the first 5 years post- transplant [ Time Frame: Day 1 ]
- Graft survival as assessed by the incidence of graft loss reported in the first 5 years post- transplant [ Time Frame: Day 1 ]
- Renal function as assessed by the absolute glomerular filtration Rate (GFR) at 5 years post-transplant [ Time Frame: Day 1 ]
- Change in Chronic Kidney Disease stages between transplant and 5 years post- transplant [ Time Frame: Day 1 ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- Withdrawal of consent to continue in the CTOT-01 study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974999
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|United States, Georgia|
|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|
|University of Manitoba Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Children's Hospital of Winnipeg|
|Winnipeg, Manitoba, Canada|
|Principal Investigator:||Peter S Heeger, MD||Icahn School of Medicine at Mount Sinai|
|Study Chair:||Donald E Hricik, MD||University Hospitals Cleveland Medical Center|
Study Data/Documents: Individual Participant Data Set
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.
ImmPort study identifier is SDY1094.
ImmPort study identifier is SDY1094.
Publications of Results:
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||November 3, 2013 Key Record Dates|
|Last Update Posted:||January 3, 2019|
|Last Verified:||December 2018|
Kidney Failure, Chronic
Renal Insufficiency, Chronic