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

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.
 
ClinicalTrials.gov Identifier: NCT00089947
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:
Sanofi

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.


Condition or disease Intervention/treatment Phase
Renal Transplantation Graft Rejection Drug: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  1. To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00089947


Locations
Show Show 19 study locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
Additional Information:
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Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00089947    
Other Study ID Numbers: SMC-101-1025
First Posted: August 20, 2004    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Sanofi:
Anti-T cell antibodies
Living Donor Renal Transplantation
Acute Renal Allograft Rejection
Induction Therapy with Reduction of Calcineurin inhibitors
Additional relevant MeSH terms:
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Thymoglobulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents