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

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

JOURNAL=Transplant International

VOLUME=Volume 35 - 2022

YEAR=2022

URL=https://www.frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2022.10839

DOI=10.3389/ti.2022.10839

ISSN=1432-2277

ABSTRACT=Malignancies and infections are major causes of death after kidney transplantation. Lowering the immunosuppressive drugs is key to diminish these complications, but has to be balanced against the risk of immunological-mediated graft loss. 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 by a recipient-donor combination with maximal 3 HLA mismatches and the absence of panel reactive antibodies. Six months after transplantation, recipients were randomized if the following critera were met: eGFR >30 ml/min, proteinuria <50 mg protein/mmol creatinine, no biopsy-proven rejection after three 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.