Status:
COMPLETED
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Renal Transplantation
Graft Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 st...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- In the opinion of the investigator, has a significant medical or psychosocial problem or unstable disease state that warrants exclusion from the study. Examples of significant problems include, but are not limited to morbid obesity and severe cardiac disease.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00089947
Start Date
June 1 2003
End Date
December 1 2005
Last Update
March 18 2015
Active Locations (19)
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1
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
2
Keck USC School of Medicine
Los Angeles, California, United States, 90033
3
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
4
University of California, San Diego Medical Center
San Diego, California, United States, 92103