The Role of ImmuKnow® in the Management of Immunosuppressants in the Renal Transplant Patient

Background: The management of renal transplant recipients is challenging in keeping a
delicate balance of immunosuppression to avoid either infection (overimmunosuppression), or
rejection (under-immunosuppression). Conventional clinical parameters are not adequate
enough. ImmuKnow (Cylex Inc, Columbia, MD) is an FDA-cleared assay for the detection of cell
mediated immune response in populations undergoing immunosuppressive therapy for organ
transplant. There have been limited retrospective studies discussing the effectiveness of
the ImmuKnow assay. There is no prospective head-to-head trial showing the benefits of
periodic ImmuKnow testing.

Objective: To demonstrate whether there are any outcome benefits of a serial ImmuKnow assays
in de novo renal transplant recipients Patients and Methods: A prospective, randomized,
pilot, controlled 12-month study to compare the outcomes of 2 cohorts of de novo renal
transplant patients will be conducted. The outcomes that will be investigated include a
combined infection rate (primary end-point), separate infection rates and episodes, acute
rejection rate and episodes, quality of life, graft and patient survivals (all secondary
end-points). Biopsy of the transplanted kidney is used to confirm rejection whenever
possible. Among the study cohort, the patients' immunosuppressants will be adjusted
according to the results of a serial ImmuKnow assay besides using conventional clinical
parameters; whereas among the control cohort the patients' immunosuppressants will be
adjusted according to conventional clinical parameters.

Expected Results: At the end of this study we will be able to learn whether the study cohort
patients have less infection, less acute rejection, better allograft function, better
quality of life, and better graft or patient survivals.

Inclusion Criteria:

1. De novo kidney transplant patients who are eligible for kidney transplant according
to UNOS criteria and agree to participate in the study.

2. Patients of both sex aged between 18 to 80 years.

Exclusion Criteria:

- Any patient with a known immunocompromised disease (e.g. patients with AIDS) or
leukocytosis(>15,000u/L)