Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients

Study Overview
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Brief Summary
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To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.

Detailed Description
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We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.

Official Title
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Prospective, Single Center, Pilot Study of Pretransplant Thymoglobulin Administration and Early Corticosteroid Withdrawal in Living Donor Renal Transplant Recipients Under Mycophenolate Mofetil (MMF) and Tacrolimus Immunosuppression

Conditions
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Renal Transplant Rejection, Transplants and Implants

Intervention / Treatment
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* Drug: Thymoglobulin
* Drug: Thymoglobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult living donor renal transplant recipient. Patient is at least 18 years of age If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis. Signed informed consent. Exclusion Criteria: Human Leukocyte Antibody (HLA) identical living donor transplant recipient. History of a positive cross-match with the donor. Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%. Patients who have previously received a kidney transplant. Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). History of noncompliance. History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. . Multiple organ transplant recipient. Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant. Patient who does not agree to use effective birth control during the 6-month efficacy analysis. Known contraindication to administration of rabbit antithymocyte globulin. Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets < 100,000/mm23 or WBC < 3000/mm3 Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance. Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rATG 4 doses<br>Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF | Drug: Thymoglobulin<br>* Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF<br>* Other names: rATG;|
| Active Comparator: rATG 3 doses<br>Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF | Drug: Thymoglobulin<br>* Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF<br>* Other names: rATG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite End Point of Acute Rejection, Graft Loss or Patient Death | Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy. |  | Ongoing | 
| Incidence of Infections |  | Not defined | 
| Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection |  | Not defined | 
| Severity of Biopsy-proven Rejection Using Banff 97 Criteria |  | Not defined | 
| Serum Creatinine |  | Post-operative days 1-7, 30, 90 and 6 months | 
| Malignancy |  | Undefined |