The Role of ImmuKnow® in the Management of Immunosuppressants in the Renal Transplant Patient
|Kidney Transplant Immunosuppression||Drug: adjustment of immunosuppressant dosages Drug: adjustment of the dosages of immunosuppressants||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|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|
- 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.
- Event numbers of infection [ Time Frame: 12 months ]1.1 Event numbers of new onset infections;1.2 Episodes of patients with moderate neutropenia (< 1000/microL), 1.3 Episodes of patients needing GCS-F; 1.4. Episodes of fever >38.5 % >= 24 hrs.
- Percentage of Infection [ Time Frame: 12 months ]2.1 percentages of patients with new onset infections; 2.2 percentages of patients with moderate neutropenia, 2.3 percentages of patients needing GCS-F injection; 2.4 percentages of fever >38.5 >= 24 hrs.
- Acute rejection [ Time Frame: 12 months ]3.1 Episodes of acute rejection; 3.2 Percentages of Acute Rejection.
- Life Quality [ Time Frame: 12 months ]4.SF-8 QOL index
- Allograft function [ Time Frame: 12 months ]5.1 serum creatinine levels 5.2 estimated GFR
- Graft Survival [ Time Frame: 12 months ]6. Graft survival
- Patient Survival [ Time Frame: 12 months ]7. Patient survival
|Study Start Date:||December 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: control group
Dosages of immunosuppressants will be given according to the results of conventional post-transplant lab
Drug: adjustment of the dosages of immunosuppressants
adjustment of the dosages of immunosuppressants will be done according to the results of conventional post-transplant follow-up lab
Experimental: ImmuKnow Study group
The dosages of immunosuppressants will be adjusted according to the results of ImmuKnow and conventional post-transplant lab
Drug: adjustment of immunosuppressant dosages
adjustment of immunosuppressant dosages according to the results of ImmuKnow results and routine post-transplant lab results
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424345
|United States, West Virginia|
|Charleston, West Virginia, United States, 25301|
|Principal Investigator:||S Jeff Chueh, MD PhD||CAMC Health System, Charleston, WV|
|Study Director:||Bashir Sankari, MD||CAMC Health System, Charleston, Wv|