Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation

This study is designed to confirm the one-year safety of single-dose rabbit anti-thymocyte
globulin induction at kidney transplantation, compared to the conventional administration of
the same overall dose divided into four smaller doses across four days. Two randomized
groups of kidney transplant recipients will be each administered the drug Thymoglobulin
according to a different dosing regimen. The control group will receive the usual and
traditional regimen of a total of 6 mg/Kg divided into 4 doses, 1 on the day of
transplantation and 1 each day on the next 3 days. The experimental group will receive the
same total Thymoglobulin dose, 6 mg/Kg, but entirely on the day of transplantation.

The study will be double-blinded, with placebo doses of Thymoglobulin administered as needed
to enrollees in the experimental group. Enrollment is targeted at 165, with 150 subjects
needed to complete the study for adequate evaluation.

Inclusion Criteria:

- Subject capable of giving written informed consent, with end-stage kidney disease,
who is a suitable candidate for primary kidney transplantation

- Male or female subject who has reached legal age in the state where they reside and
is at least 18 years of age

- Deceased or living donors

- Compatible ABO blood type

- Expanded-criteria donor (ECD) kidneys with a donor grade score of ≤ 25 (as developed
by Nyberg, et al.)

- If Kidneys are pumped, they must meet the following pumping parameters: resistance
<0.35 with a flow rate of >60 ml/min.

Exclusion Criteria:

- Recipient age >65 years

- PRA >50%, or donor-specific antibody

- CIT >30 hours

- Re-transplant patients

- Multi-organ transplant recipients (example: kidney/pancreas or kidney/liver)

- Renal transplant recipients planned for future pancreas transplantation

- Current unstable cardiovascular disease or history of myocardial infarction within
the previous 6 months

- Current malignancy or history or malignancy (within the previous 5 years) with the
exception of non-metastatic basal or squamous cell carcinoma of the skin or carcinoma
in-situ of the cervix that has been treated successfully.

- Hepatitis B and C recipients or active liver disease

- HIV positive recipients

- Primary disease requiring treatment with steroids after transplantation

- Expanded-criteria donor kidneys (current UNOS criteria) with a donor grade score of >
25

- Donation after cardiac death (DCD) donors

- Dual adult kidneys

- Recipients of pediatric (age <12 years) unilateral or en-bloc kidneys

- Previous treatment with rATG

- Known hypersensitivity, extensive exposure, or allergy to rabbits

- Pregnant

- Any condition that in the investigator's opinion may compromise study participation
(e.g., history or likelihood of non-compliance with immunosuppression regimen,
protocol visits, tests, and studies)

Relative Exclusion Criteria:

- Patients with a BMI > 37 should be considered on an individual basis based on overall
health and body habitus.