A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00089947
First received: August 18, 2004
Last updated: August 10, 2012
Last verified: August 2012

August 18, 2004
August 10, 2012
June 2003
December 2005   (final data collection date for primary outcome measure)
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.
This study will evaluate the effect of Thymoglobulin induction therapy on the rate of renal transplant rejection at 6 months
Complete list of historical versions of study NCT00089947 on ClinicalTrials.gov Archive Site
To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Transplantation
  • Graft Rejection
Drug: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089947
SMC-101-1025
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP