Background There is high medical need for safe long-term immunosuppression
monotherapy in kidney transplantation. Selective targeting of post-transplant
alloantigen-(re)activated effector-T cells by anti-TNF antibodies after global
T cell depletion may allow safe drug minimization, however, it is unsolved
what might be the best maintenance monotherapy. Methods In this open,
prospective observational single-centre trial, 20 primary deceased donor
kidney transplant recipients received 2x20 mg Alemtuzumab (d0/d1) followed by
5 mg/kg Infliximab (d2). For 14 days all patients received only tacrolimus,
then they were allocated to either receive tacrolimus (TAC, n = 13) or
sirolimus (SIR, n = 7) monotherapy, respectively. Protocol biopsies and
extensive immune monitoring were performed and patients were followed-up for
60 months. Results TAC-monotherapy resulted in excellent graft survival (5yr
92%, 95%CI: 56.6–98.9) and function, normal histology, and no proteinuria.
Immune monitoring revealed low intragraft inflammation (urinary IP-10) and
hints for the development of operational tolerance signature in the TAC- but
not SIR-group. Remarkably, the TAC-monotherapy was successful in all five
presensitized (ELISPOT+) patients. However, recruitment into SIR-arm was
stopped (after n = 7) because of high incidence of proteinuria and
acute/chronic rejection in biopsies. No opportunistic infections occurred
during follow-up. Conclusions In conclusion, our novel fast-track TAC-
monotherapy protocol is likely to be safe and preliminary results indicated an
excellent 5-year outcome, however, a full–scale study will be needed to
confirm our findings. Trial Registration EudraCT Number: 2006-003110-1