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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- the combo-infection rates of the 2 cohorts of renal transplant recipients within the 12-month period after a de novo kidney transplantation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •De novo kidney transplant patients who are eligible for kidney transplant according to UNOS criteria and agree to participate in the study.
- •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)
Arms & Interventions
control group
Dosages of immunosuppressants will be given according to the results of conventional post-transplant lab
Intervention: adjustment of the dosages of immunosuppressants (Drug)
ImmuKnow Study group
The dosages of immunosuppressants will be adjusted according to the results of ImmuKnow and conventional post-transplant lab
Intervention: adjustment of immunosuppressant dosages (Drug)
Outcomes
Primary Outcomes
the combo-infection rates of the 2 cohorts of renal transplant recipients within the 12-month period after a de novo kidney transplantation
Time Frame: 12 months
The combo-infection is defined as: If a patient either has new onset culture/or serology/or PCR positive bacterial or viral infections; or moderate neutropenia (absolute netrophile count \< 1000/microL) or need GCS-F injection or has fever \>38.5 % for longer than 24 hrs then he/she is called to have combo- infection. Percentage of such patients will be compared in Immuknow vs. control group.
Secondary Outcomes
- Event numbers of infection(12 months)
- Percentage of Infection(12 months)
- Acute rejection(12 months)
- Life Quality(12 months)
- Allograft function(12 months)
- Graft Survival(12 months)
- Patient Survival(12 months)
Investigators
SC Jeff Chueh, MD
Primary Surgeon, UNOS, CAMC-WV kidney transplant program
CAMC Health System