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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Transplantation, Graft Rejection

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-T cell antibodies, Living Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy with Reduction of Calcineurin inhibitors