Universität zu Köln

Ahlenstiel-Grunow, Thurid, Liu, Xiaofei ORCID: 0000-0003-0092-5233, Schild, Raphael, Oh, Jun, Taylan, Christina, Weber, Lutz T., Staude, Hagen, Verboom, Murielle, Schroeder, Christoph, Sabau, Ruxandra, Grosshennig, Anika and Pape, Lars (2021). Steering Transplant Immunosuppression by Measuring Virus-Specific T Cell Levels: The Randomized, Controlled IVIST Trial. J. Am. Soc. Nephrol., 32 (2). S. 502 - 517. WASHINGTON: AMER SOC NEPHROLOGY. ISSN 1533-3450

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Abstract

Background Pharmacokinetic monitoring is insufficient to estimate the intensity of immunosuppression after transplantation. Virus-specific T cells correlate with both virus-specific and general cellular immune defense. Additional steering of immunosuppressive therapy by virus-specific T cell levels might optimize dosing of immunosuppressants. Methods In a multicenter, randomized, controlled trial, we randomized 64 pediatric kidney recipients to a control group with trough-level monitoring of immunosuppressants or to an intervention group with additional steering of immunosuppressive therapy by levels of virus-specific T cells (quantified by cytokine flow cytometry). Both groups received immunosuppression with cyclosporin A and everolimus in the same target range of trough levels. Primary end point was eGFR 2 years after transplantation. Results In the primary analysis, we detected no difference in eGFR for the intervention and control groups 2 years after transplantation, although baseline eGFR 1 month after transplantation was lower in the intervention group versus the control group. Compared with controls, patients in the intervention group received significantly lower daily doses of everolimus and nonsignificantly lower doses of cyclosporin A, resulting in significantly lower trough levels of everolimus (3.5 versus 4.5 mu g/L, P<0.001) and cyclosporin A (47.4 versus 64.1 mu g/L, P<0.001). Only 20% of patients in the intervention group versus 47% in the control group received glucocorticoids 2 years after transplantation (P=0.04). The groups had similar numbers of donor-specific antibodies and serious adverse events. Conclusions Steering immunosuppressive therapy by virus-specific T cell levels in addition to pharmacokinetic monitoring seems safe, results in a similar eGFR, and personalizes immunosuppressive therapy by lowering exposure to immunosuppressive drugs, likely resulting in lower drug costs.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ahlenstiel-Grunow, Thurid UNSPECIFIED UNSPECIFIED UNSPECIFIED Liu, Xiaofei UNSPECIFIED orcid.org/0000-0003-0092-5233 UNSPECIFIED Schild, Raphael UNSPECIFIED UNSPECIFIED UNSPECIFIED Oh, Jun UNSPECIFIED UNSPECIFIED UNSPECIFIED Taylan, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Weber, Lutz T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Staude, Hagen UNSPECIFIED UNSPECIFIED UNSPECIFIED Verboom, Murielle UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroeder, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Sabau, Ruxandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Grosshennig, Anika UNSPECIFIED UNSPECIFIED UNSPECIFIED Pape, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-593994
DOI:	10.1681/ASN.2020050645
Journal or Publication Title:	J. Am. Soc. Nephrol.
Volume:	32
Number:	2
Page Range:	S. 502 - 517
Date:	2021
Publisher:	AMER SOC NEPHROLOGY
Place of Publication:	WASHINGTON
ISSN:	1533-3450
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Urology & Nephrology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59399