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

October 4, 2012 updated by: SC Jeff Chueh, MD, CAMC Health System

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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • CAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Acute rejection
Time Frame: 12 months
3.1 Episodes of acute rejection; 3.2 Percentages of Acute Rejection.
12 months
Life Quality
Time Frame: 12 months
4.SF-8 QOL index
12 months
Allograft function
Time Frame: 12 months
5.1 serum creatinine levels 5.2 estimated GFR
12 months
Graft Survival
Time Frame: 12 months
6. Graft survival
12 months
Patient Survival
Time Frame: 12 months
7. Patient survival
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (ESTIMATE)

August 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2012

Last Update Submitted That Met QC Criteria

October 4, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1997050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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