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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 4, 2013
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date October 28, 2013
First Posted Date November 4, 2013
Last Update Posted Date January 3, 2019
Study Start Date October 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 28, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01974999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 28, 2013)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study
Official Title A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Kidney Disease
  • Kidney Failure
  • End Stage Renal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 31, 2018)
184
Original Estimated Enrollment
 (submitted: October 28, 2013)
243
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01974999
Other Study ID Numbers DAIT CTOT-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators 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
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date December 2018