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Randomized Controlled Trial
. 2022 Oct 24:35:10839.
doi: 10.3389/ti.2022.10839. eCollection 2022.

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

Annelies E de Weerd  1 , Zainab Al Fatly  1 , Marieken Boer-Verschragen  1 , Judith A Kal-van Gestel  1 , Dave L Roelen  2 , Marjolein Dieterich  1 , Michiel G H Betjes  1
Affiliations
Randomized Controlled Trial

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

Annelies E de Weerd et al. Transpl Int. .

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.

Keywords: immunosuppression reduction; infection; kidney transplantation; mycophenolate mofetil; rejection; tacrolimus.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart of the selection of recipients included in the study.
FIGURE 2
FIGURE 2
Death-censored graft survival (A) and patient survival (B) in kidney transplant recipients treated with either tacrolimus monotherapy or with standard tacrolimus/mycophenolate mofetil. Survival is shown by Kaplan-Meier cumulative survival curves. The group of recipients randomized to tacrolimus monotherapy (TACmono) or standard tacrolimus with mycophenolate mofetil (TAC/MMF) are shown as separate curves.
FIGURE 3
FIGURE 3
Kidney function (A) and proteinuria (B) in kidney transplant recipients treated with either tacrolimus monotherapy or with standard tacrolimus/mycophenolate mofetil. The eGFR (CKD-EPI formula) and proteinuria (in spot urine) is shown in the years after transplantation. The group of recipients randomized to tacrolimus monotherapy (TACmono) or standard tacrolimus with mycophenolate mofetil (TAC/MMF) are shown as separate data points.
See this image and copyright information in PMC

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