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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplantation; Graft Rejection

Intervention: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Locations and Contacts

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

Additional Information

US FDA Approved Full Prescribing Information for Thymoglobulin®

Starting date: June 2003
Last updated: March 16, 2015

Page last updated: August 23, 2015

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