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Trial record 1 of 1 for:    ctot17
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A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01974999
First Posted: November 4, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  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)

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 ]
    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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
Information from the National Library of Medicine

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


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:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
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  This link exits the ClinicalTrials.gov site
Identifier: SDY1094
ImmPort study identifier is SDY 1094.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01974999     History of Changes
Other Study ID Numbers: DAIT CTOT-17
First Submitted: October 28, 2013
First Posted: November 4, 2013
Last Update Posted: November 6, 2017
Last Verified: November 2017

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