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Kidney Transplant ImmunosuppressionPhase 4NCT01424345

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

A Phase 4 study testing adjustment of immunosuppressant dosages and adjustment of the dosages of immunosuppressants in people with Kidney Transplant Immunosuppression, run by CAMC Health System at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Kidney Transplant Immunosuppression
What is being tested?
adjustment of immunosuppressant dosages and adjustment of the dosages of immunosuppressants
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Dec 2011to Jul 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Any patient with a known immunocompromised disease (e.g. patients with AIDS) or leukocytosis(>15,000u/L)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CAMC

    Charleston, West Virginia, 25301

Other trials in United States

About this study

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 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.

Read the 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.

Being tested
adjustment of immunosuppressant dosages, adjustment of the dosages of immunosuppressants
Keywords
Kidney Transplantation, Immunosuppression, Immune monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adjustment of immunosuppressant dosagesDrug

    adjustment of immunosuppressant dosages according to the results of ImmuKnow results and routine post-transplant lab results

  • adjustment of the dosages of immunosuppressantsDrug

    adjustment of the dosages of immunosuppressants will be done according to the results of conventional post-transplant follow-up lab

Study groups in NCT01424345
Study groupRoleWhat they receive
control groupActive comparatorDosages of immunosuppressants will be given according to the results of conventional post-transplant lab
Receives: Drug: adjustment of the dosages of immunosuppressants
ImmuKnow Study groupExperimentalThe dosages of immunosuppressants will be adjusted according to the results of ImmuKnow and conventional post-transplant lab
Receives: Drug: adjustment of immunosuppressant dosages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the combo-infection rates of the 2 cohorts of renal transplant recipients within the 12-month period after a de novo kidney transplantation

    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.

    Measured: 12 months

Secondary outcomes (7)

  1. Event numbers of infection

    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.

    Measured: 12 months

  2. Percentage of Infection

    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.

    Measured: 12 months

  3. Acute rejection

    3.1 Episodes of acute rejection; 3.2 Percentages of Acute Rejection.

    Measured: 12 months

  4. Life Quality

    4.SF-8 QOL index

    Measured: 12 months

  5. Allograft function

    5.1 serum creatinine levels 5.2 estimated GFR

    Measured: 12 months

  6. Graft Survival

    1. Graft survival

    Measured: 12 months

  7. Patient Survival

    1. Patient survival

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Why it stopped: The PI is relocating to another State/ another hospital

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01424345
Sponsor's protocol ID
1997050
Status last verified
Mar 2026
First submitted
24 Aug 2011
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No

Publications

  • Kowalski RJ, Post DR, Mannon RB, Sebastian A, Wright HI, Sigle G, Burdick J, Elmagd KA, Zeevi A, Lopez-Cepero M, Daller JA, Gritsch HA, Reed EF, Jonsson J, Hawkins D, Britz JA. Assessing relative risks of infection and rejection: a meta-analysis using an immune function assay. Transplantation. 2006 Sep 15;82(5):663-8. doi: 10.1097/01.tp.0000234837.02126.70.

    PubMed 16969290

  • Reinsmoen NL, Cornett KM, Kloehn R, Burnette AD, McHugh L, Flewellen BK, Matas A, Savik K. Pretransplant donor-specific and non-specific immune parameters associated with early acute rejection. Transplantation. 2008 Feb 15;85(3):462-70. doi: 10.1097/TP.0b013e3181612ead.

    PubMed 18301338

  • Gautam A, Fischer SA, Yango AF, Gohh RY, Morrissey PE, Monaco AP. Cell mediated immunity (CMI) and post transplant viral infections--role of a functional immune assay to titrate immunosuppression. Int Immunopharmacol. 2006 Dec 20;6(13-14):2023-6. doi: 10.1016/j.intimp.2006.09.023. Epub 2006 Oct 24.

    PubMed 17161357

  • Batal I, Zeevi A, Heider A, Girnita A, Basu A, Tan H, Shapiro R, Randhawa P. Measurements of global cell-mediated immunity in renal transplant recipients with BK virus reactivation. Am J Clin Pathol. 2008 Apr;129(4):587-91. doi: 10.1309/23YGPB1E758ECCFP.

    PubMed 18343786

  • Sanchez-Velasco P, Rodrigo E, Valero R, Ruiz JC, Fernandez-Fresnedo G, Lopez-Hoyos M, Pinera C, Palomar R, Leyva-Cobian F, Arias M. Intracellular ATP concentrations of CD4 cells in kidney transplant patients with and without infection. Clin Transplant. 2008 Jan-Feb;22(1):55-60. doi: 10.1111/j.1399-0012.2007.00744.x.

    PubMed 18217906

  • Kowalski R, Post D, Schneider MC, Britz J, Thomas J, Deierhoi M, Lobashevsky A, Redfield R, Schweitzer E, Heredia A, Reardon E, Davis C, Bentlejewski C, Fung J, Shapiro R, Zeevi A. Immune cell function testing: an adjunct to therapeutic drug monitoring in transplant patient management. Clin Transplant. 2003 Apr;17(2):77-88. doi: 10.1034/j.1399-0012.2003.00013.x.

    PubMed 12709071

  • Kobashigawa JA, Kiyosaki KK, Patel JK, Kittleson MM, Kubak BM, Davis SN, Kawano MA, Ardehali AA. Benefit of immune monitoring in heart transplant patients using ATP production in activated lymphocytes. J Heart Lung Transplant. 2010 May;29(5):504-8. doi: 10.1016/j.healun.2009.12.015. Epub 2010 Feb 4.

    PubMed 20133166

  • Huskey J, Gralla J, Wiseman AC. Single time point immune function assay (ImmuKnow) testing does not aid in the prediction of future opportunistic infections or acute rejection. Clin J Am Soc Nephrol. 2011 Feb;6(2):423-9. doi: 10.2215/CJN.04210510. Epub 2010 Nov 18.

    PubMed 21088287

  • Knight RJ, Kerman RH, McKissick E, Lawless A, Podder H, Katz S, Van Buren CT, Kahan BD. Selective corticosteroid and calcineurin-inhibitor withdrawal after pancreas-kidney transplantation utilizing thymoglobulin induction and sirolimus maintenance therapy. Clin Transplant. 2008 Sep-Oct;22(5):645-50. doi: 10.1111/j.1399-0012.2008.00839.x. Epub 2008 Jul 24.

    PubMed 18657156

  • John Ware, Jr, Ph.D., Mark Kosinski, M.A., James E. Dewey, Ph.D., Barbara Gandek, M.S. How to score & interpret single item health status measures. Manual for users of SF8, Lincdn, RI. Quality Metric Incorporated, 2001. 1998-2001

  • 1. ImmuKnow®® Cylex™ Immune Cell Function Assay, Package Insert (http://www.cylex.net/pdf/ImmuKnow_Insert-cx.pdf)

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adjustment of immunosuppressant dosages and adjustment of the dosages of immunosuppressants in people with Kidney Transplant Immunosuppression, run by CAMC Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The PI is relocating to another State/ another hospital). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01424345, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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