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

CAMC Health System

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplant Immunosuppression

Treatments: Drug: adjustment of the dosages of immunosuppressants; Drug: adjustment of immunosuppressant dosages

Study type: Interventional

Funder types: Other

Identifiers

NCT01424345

1997050

Details and patient eligibility

About

The purpose of this study is to demonstrate whether there are any outcome benefits of a serial ImmuKnow assays in the management of de novo renal transplant recipients.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

control group

Active Comparator group

Description:

Dosages of immunosuppressants will be given according to the results of conventional post-transplant lab

Treatment:

Drug: adjustment of the dosages of immunosuppressants

ImmuKnow Study group

Experimental group

Description:

The dosages of immunosuppressants will be adjusted according to the results of ImmuKnow and conventional post-transplant lab

Treatment:

Drug: adjustment of immunosuppressant dosages