Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients
NCT ID: NCT00308802
Last Updated: 2013-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
280 participants
OBSERVATIONAL
2006-03-31
2011-07-31
Brief Summary
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Detailed Description
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This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Kidney transplantation
Participants in this study will have had a kidney transplant
Eligibility Criteria
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Inclusion Criteria
* Negative Crossmatch
* Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria
* Other illnesses that, in the opinion of the investigator, may interfere with the study
* Recipient of multiple organ transplants
* Inability or unwillingness to comply with the study protocol
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Peter S. Heeger, MD
Role: STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai
Donald Hricik, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
David Rush, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba at Winnipeg
Kenneth Newell, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Richard Formica, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Emilio Poggio, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Barry Warshaw, MD
Role: PRINCIPAL_INVESTIGATOR
Emory-Children's Center
Enver Akalin, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Patricia Birk, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Winnipeg
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Emory Children's Center
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Mount Sinai School of Medicine
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Countries
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References
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Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. Ther Drug Monit. 2002 Feb;24(1):36-9. doi: 10.1097/00007691-200202000-00007.
Meier-Kriesche HU, Schold JD, Kaplan B. Long-term renal allograft survival: have we made significant progress or is it time to rethink our analytic and therapeutic strategies? Am J Transplant. 2004 Aug;4(8):1289-95. doi: 10.1111/j.1600-6143.2004.00515.x.
Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS; CTOT-01 consortium. Multicenter validation of urinary CXCL9 as a risk-stratifying biomarker for kidney transplant injury. Am J Transplant. 2013 Oct;13(10):2634-44. doi: 10.1111/ajt.12426. Epub 2013 Aug 22.
Related Links
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Click here for the Clinical Trials in Organ Transplantation (CTOT) public Web site
Other Identifiers
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DAIT CTOT-01
Identifier Type: -
Identifier Source: org_study_id