NCT01424345

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

August 24, 2011

Last Update Submit

March 18, 2026

Conditions

Kidney Transplant Immunosuppression

Keywords

Kidney TransplantationImmunosuppressionImmune monitoring

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (7)

  • Event numbers of infection

    12 months

  • Percentage of Infection

    12 months

  • Acute rejection

    12 months

  • Life Quality

    12 months

  • Allograft function

    12 months

  • +2 more secondary outcomes

Study Arms (2)

control group

ACTIVE COMPARATOR

Dosages of immunosuppressants will be given according to the results of conventional post-transplant lab

Drug: adjustment of the dosages of immunosuppressants

ImmuKnow Study group

EXPERIMENTAL

The dosages of immunosuppressants will be adjusted according to the results of ImmuKnow and conventional post-transplant lab

Drug: adjustment of immunosuppressant dosages

Interventions

adjustment of immunosuppressant dosagesDRUG

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

ImmuKnow Study group
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

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMC

Charleston, West Virginia, 25301, United States

Location

Related Publications (11)

  • 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.

    PMID: 16969290BACKGROUND

  • 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.

    PMID: 18301338BACKGROUND

  • 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.

    PMID: 17161357BACKGROUND

  • 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.

    PMID: 18343786BACKGROUND

  • 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.

    PMID: 18217906BACKGROUND

  • 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.

    PMID: 12709071BACKGROUND

  • 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.

    PMID: 20133166BACKGROUND

  • 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.

    PMID: 21088287BACKGROUND

  • 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.

    PMID: 18657156BACKGROUND

  • 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

    BACKGROUND

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

    RESULT

Study Officials

  • S Jeff Chueh, MD PhD

    CAMC Health System, Charleston, WV

    PRINCIPAL INVESTIGATOR

  • Bashir Sankari, MD

    CAMC Health System, Charleston, Wv

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 29, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

US(1)