Clinical trial NCT01424345: The Role of ImmuKnow® in the Management of Immunosuppressants in the Renal Transplant Patient
Official title: A Randomized, Controlled Trial Evaluating the Role of ImmuKnow® in the Management of Immunosuppressants Regarding Opportunistic Infections and Acute Rejection in the Renal Transplant Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant Immunosuppression
Keywords: Kidney Transplantation
Immunosuppression
Immune monitoring
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: the combo-infection rates of the 2 cohorts of renal transplant recipients within the 12-month period after a de novo kidney transplantation
timeFrame: 12 months
Secondary outcomes:
measure: Event numbers of infection
timeFrame: 12 months
measure: Percentage of Infection
timeFrame: 12 months
measure: Acute rejection
timeFrame: 12 months
measure: Life Quality
timeFrame: 12 months
measure: Allograft function
timeFrame: 12 months
measure: Graft Survival
timeFrame: 12 months
measure: Patient Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: CAMC
state: West Virginia
Study officials:
affiliation: CAMC Health System, Charleston, WV
name: S Jeff Chueh, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMC Health System, Charleston, Wv
name: Bashir Sankari, MD
role: STUDY_DIRECTOR
References:
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citation: 1. ImmuKnow®® Cylex™ Immune Cell Function Assay, Package Insert (http://www.cylex.net/pdf/ImmuKnow_Insert-cx.pdf)