Tacrolimus Monotherapy is Safe in Immunologically Low-Risk Kidney Transplant Recipients: A Randomized-Controlled Pilot Study

Annelies E. de Weerd*, Zainab Al Fatly, Marieken Boer-Verschragen, Judith A. Kal-van Gestel, Dave L. Roelen, Marjolein Dieterich, Michiel G.H. Betjes

*Corresponding author for this work

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Abstract

In this randomized-controlled pilot study, the feasibility and safety of tacrolimus monotherapy in immunologically low-risk kidney transplant recipients was evaluated [NTR4824, www.trialregister.nl]. Low immunological risk was defined as maximal 3 HLA mismatches and the absence of panel reactive antibodies. Six months after transplantation, recipients were randomized if eGFR >30 ml/min, proteinuria <50 mg protein/mmol creatinine, no biopsy-proven rejection after 3 months, and no lymphocyte depleting therapy given. Recipients were randomized to tacrolimus/mycophenolate mofetil (TAC/MMF) or to taper and discontinue MMF at month 9 (TACmono). 79 of the 121 recipients were randomized to either TACmono (n = 38) or TAC/MMF (n = 41). Mean recipient age was 59 years and 59% received a living donor transplant. The median follow-up was 62 months. After randomization, 3 TACmono and 4 TAC/MMF recipients experienced a biopsy-proven rejection. At 5 years follow-up, patient survival was 84% in TACmono versus 76% in TAC/MMF with death-censored graft survival of 97% for both groups and no differences in eGFR and proteinuria. Eleven TACmono recipients had an infectious episode versus 22 TAC/MMF recipients (p < 0.03). Donor-specific anti-HLA antibodies were not detected during follow-up in both groups. Tacrolimus monotherapy in selected immunologically low-risk kidney transplant recipients appears safe and reduces the number of infections.

Original languageEnglish
Article number10839
JournalTransplant International
Volume35
DOIs
Publication statusPublished - 24 Oct 2022

Bibliographical note

Funding Information:
Simone Brand-Schaaf kindly provided the Luminex screening and single antigen bead data.

Publisher Copyright:
Copyright © 2022 de Weerd, Fatly, Boer-Verschragen, Kal-van Gestel, Roelen, Dieterich and Betjes.

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