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

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
rATG 3 doses	Thymoglobulin	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
rATG 4 doses	Thymoglobulin	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

Primary Outcome Measures

Name	Time	Method
Composite End Point of Acute Rejection, Graft Loss or Patient Death	6 months	Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death

Secondary Outcome Measures

Name	Time	Method
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