SMC1011025: A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00089947

Purpose

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	Intervention	Phase
Renal Transplantation Graft Rejection	Drug: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]	Phase II

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details:

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

Expected Total Enrollment: 150

Study start: June 2003; Study completion: December 2005

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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.

Location Information

Arkansas
University of Arkansas for Medical Science, Little Rock, Arkansas, 72205, United States

California
University of California, San Francisco, San Francisco, California, 94143, 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
Keck USC School of Medicine, Los Angeles, California, 90033, United States
California Pacific Medical Center, San Francisco, California, 94115, United States

Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States

Georgia
Emory University, Atlanta, Georgia, 30322, United States

Indiana
Indiana University, Indianapolis, Indiana, 46202, United States

Louisiana
Oschner Medical Center, New Orleans, Louisiana, 70121, United States

Maryland
Johns Hopkins University Hospital, Baltimore, Maryland, 21287, United States

New Jersey
Saint Barnabas Medical Center, Livingston, New Jersey, 07039, United States

New York
Mount Sinai School of Medicine, New York, New York, 10029, United States

North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States

Ohio
University of Cincinnati Medical Center, Cincinnati, Ohio, 45267, United States
Christ Hospital, Cincinnati, Ohio, 45219, United States

Texas
Texas Transplant Institute, San Antonio, Texas, 78229, United States

Virginia
Medical College of Virginia, Richmond, Virginia, 23298, United States

Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States

More Information

US FDA Approved Full Prescribing Information for Thymoglobulin®

Study ID Numbers: SMC1011025
ClinicalTrials.gov Identifier: NCT00089947
Health Authority: United States: Food and Drug Administration