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

Study Description

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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

Study Design

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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

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

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Locations

United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
United States, California
Keck USC School of Medicine
Los Angeles, California, United States, 90033
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
University of California, San Diego Medical Center
San Diego, California, United States, 92103
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Oschner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins University Hospital
Baltimore, Maryland, United States, 21287
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Christ Hospital
Cincinnati, Ohio, United States, 45219
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Texas
Texas Transplant Institute
San Antonio, Texas, United States, 78229
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director:	Medical Monitor	Genzyme, a Sanofi Company

More Information

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Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00089947 History of Changes
Other Study ID Numbers:	SMC-101-1025
First Posted:	August 20, 2004
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:

Thymoglobulin; Antilymphocyte Serum; Immunologic Factors; Physiological Effects of Drugs; Immunosuppressive Agents