The PI is relocating to another State/ another hospital
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
Sponsor study identifier
interventional
4
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2011
Actual (reported)August 29, 2011
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 2012
Actual (reported)July 2012
Actual (reported)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
Event numbers of infection
12 months
Percentage of Infection
12 months
Acute rejection
12 months
Life Quality
12 months
Allograft function
12 months
Dosages of immunosuppressants will be given according to the results of conventional post-transplant lab
The dosages of immunosuppressants will be adjusted according to the results of ImmuKnow and conventional post-transplant lab
adjustment of immunosuppressant dosages according to the results of ImmuKnow results and routine post-transplant lab results
adjustment of the dosages of immunosuppressants will be done according to the results of conventional post-transplant follow-up lab
CAMC
Charleston, West Virginia, 25301, United States
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.
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.
S Jeff Chueh, MD PhD
CAMC Health System, Charleston, WV
Bashir Sankari, MD
CAMC Health System, Charleston, Wv
4 participants (actual enrollment reported by the registry).
First Submitted
August 24, 2011
First Posted
August 29, 2011
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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)
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
March 20, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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