To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
11
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
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
The Christ Hospital
Cincinnati, Ohio, United States
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
Time frame: 6 months
Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.
Time frame: Ongoing
Incidence of Infections
Time frame: Not defined
Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection
Time frame: Not defined
Severity of Biopsy-proven Rejection Using Banff 97 Criteria
Time frame: Not defined
Serum Creatinine
Time frame: Post-operative days 1-7, 30, 90 and 6 months
Malignancy
Time frame: Undefined
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