Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a randomized controlled trial

A.E. de Weerd, M.J. Verschragen, J.A. van Gestel, M.G.H. Betjes

Wednesday 13 march 2019

16:50 - 17:00h at Koningin Máximazaal

Categories: Best abstracts, Parallelsessie

Parallel session: Parallelsessie VI – Best abstracts I

Background: Attempts to wean immunosuppressive drugs in order to diminish infection and malignancy must be balanced to prevent rejection. Tacrolimus combined with mycophenolate mofetil is the cornerstone of current immunosuppressive regimens. We have performed a randomized controlled trial to investigate the safety of discontinuing mycophenolate mofetil.

Methods: Patients without an immunological renal disease with ≤3 mismatches with their donor and peak panel-reactive antibodies (PRA) of ≤4% were asked for their consent at admission. Steroids were tapered and discontinued at month 5. After a run-in period of 6 months, patients with eGFR >30 ml/min, proteinuria

Results: 718 patients received a kidney transplant (living and deceased donor) between August 2014 and April 2018. 24% of them met inclusion criteria. At admission, 121 patients were included. After the 6 month run-in period 79 recipients were randomized to TACmono (n=38) or TAC/MMF (n=41). Baseline characteristics were similar for TACmono versus TAC/MMF with a mean recipient age of 59.6 vs 59.0 years, mean donor age of 48.5 and 48.8 years, percentage male 76% vs 71% and pre-emptive transplantation in 37% vs 34% of recipients. TAC trough levels were 7.5 and 7.2 ug/L at randomization. 3 TACmono and 2 TAC/MMF recipients experienced biopsy-proven acute rejection. Rejection episodes were reversible with methylprednisolone an reinitiating MMF. Renal function was significantly better after 12 months in TACmono recipients (61.7 vs 52.1 umol/L, p=0.04 per protocol analysis and 59.7 vs 52.1 umol/L, p=0.09 intentention to treat). TAC trough levels were similar 6.4 vs 6.1 (p=0.4). No allograft losses or patient deaths have occurred in 15 months follow-up.

We are currently analyzing vaccination responses and infectious episodes.

Conclusions: Tacrolimus monotherapy in immunologically low-risk recipients 9 months after kidney transplantation is safe.