Single Dose rATG for Renal Allograft Rejection

Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection
following kidney transplantation and is routinely administered as a series of 5-7 consecutive
daily doses via central intravenous catheter. This prolonged course is not consistent with
the Medicare diagnosis-related group (DRG) for acute rejection which limits rejection
admission to 3 days. The prolonged hospitalization results in increased medical costs and
uniform financial loss to the hospital for patients admitted under this DRG. In addition
there is a patient related toll of the prolonged hospitalization and a potential for
additional hospital acquired complications. Single large-doses of rATG have been shown to
have equivalent safety and efficacy profile compared to the standard daily protocol when used
as an induction agent but there are no reported experiences of its use for rejection
treatment. The investigators hypothesize that single-dose rATG infusion will be as safe and
efficacious as standard rATG administration when used for rejection treatment and would
result in significant reduction in the length of hospital stay (LOS) and hospital costs for
rejection treatment.

Inclusion Criteria:

1. Male or female subjects aged 18 years or older

2. Experiencing a biopsy-proven acute rejection episode which:

- will require the use of rATG based on severity, or

- is exhibiting resistance to corticosteroid treatment, defined as failure of the
serum creatinine to decrease after at least 3 days of corticosteroid treatment
(≥200 mg/day of methylprednisolone or equivalent)

Exclusion Criteria:

1. Patients with known severe allergy to antithymocyte globulin or rabbits

2. Rejection episode requiring the use of therapeutic plasma exchange immediately
subsequent to rATG administration

3. Currently receiving any investigational drug or treatments