A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
Randomized, Prospective, Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol With Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy
1 other identifier
interventional
150
1 country
19
Brief Summary
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. In addition to standard treatment, study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. The treatment assignment is random and is not chosen by the subject or their physician. Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the transplant. Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2003
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 18, 2004
CompletedFirst Posted
Study publicly available on registry
August 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 18, 2015
March 1, 2015
2.5 years
August 18, 2004
March 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection, organ loss and death at 6 months.
Secondary Outcomes (1)
To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.
Interventions
Eligibility Criteria
You may qualify if:
- Adult living donor renal transplant recipient
- Age greater than or equal to 18
- If female and of childbearing potential: a) must not be lactating; b) must have a negative serum B-human chorionic gonadotropin (HCG) test within 24 hours prior to Study Day 0 (Day of Transplant) and; c) must agree to practice an acceptable and reliable form of contraception during the study; and
- Signed informed consent
You may not qualify if:
- Human Leukocyte Antibody (HLA) identical matched living donor transplant recipient
- \> 2 previous transplants
- Current panel reactive antibody (PRA) \> 20%
- History of a positive cross-match with the donor
- Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
- Loss of first kidney transplant in \< 1 year
- History of noncompliance in clinical trial(s)
- History of chronic CS or immunosuppressive use except for inhaled CS to treat asthma
- Use of any investigational products during the 90 days prior to screening
- Requirement for multiple organ transplant
- Patient without a functioning urinary bladder prior to transplant (e.g. patients with self catheterization will be excluded)
- Known contraindication to administration of rabbit antithymocyte globulin
- Currently abusing drugs or alcohol
- In the opinion of the investigator, at high risk for poor compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205, United States
Keck USC School of Medicine
Los Angeles, California, 90033, United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90095, United States
University of California, San Diego Medical Center
San Diego, California, 92103, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Emory University
Atlanta, Georgia, 30322, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Oschner Medical Center
New Orleans, Louisiana, 70121, United States
Johns Hopkins University Hospital
Baltimore, Maryland, 21287, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Medical College of Virginia
Richmond, Virginia, 23298, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 18, 2004
First Posted
August 20, 2004
Study Start
June 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
March 18, 2015
Record last verified: 2015-03