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

This study has been terminated.
(The PI is relocating to another State/ another hospital)
Sponsor:
Information provided by (Responsible Party):
SC Jeff Chueh, MD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01424345
First received: August 24, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Kidney Transplant Immunosuppression
Drug: adjustment of immunosuppressant dosages
Drug: adjustment of the dosages of immunosuppressants
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Event numbers of infection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    3.1 Episodes of acute rejection; 3.2 Percentages of Acute Rejection.

  • Life Quality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    4.SF-8 QOL index

  • Allograft function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    5.1 serum creatinine levels 5.2 estimated GFR

  • Graft Survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    6. Graft survival

  • Patient Survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    7. Patient survival


Estimated Enrollment: 40
Study Start Date: December 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424345

Locations
United States, West Virginia
CAMC
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: S Jeff Chueh, MD PhD CAMC Health System, Charleston, WV
Study Director: Bashir Sankari, MD CAMC Health System, Charleston, Wv
  More Information

Publications:

Responsible Party: SC Jeff Chueh, MD, Primary Surgeon, UNOS, CAMC-WV kidney transplant program, CAMC Health System
ClinicalTrials.gov Identifier: NCT01424345     History of Changes
Other Study ID Numbers: 1997050
Study First Received: August 24, 2011
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Kidney Transplantation
Immunosuppression
Immune monitoring

Additional relevant MeSH terms:
Opportunistic Infections
Infection
Virus Diseases
Parasitic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014