Minimization of maintenance immunosuppressive therapy after renal transplantation comparing cyclosporine A/azathioprine or cyclosporine A/mycophenolate mofetil bitherapy to cyclosporine A monotherapy: a 10-year postrandomization follow-up study.Thierry A, Lemeur Y, et al.
Transplant International 2016; 29(1): 23-33.
To compare the long-term results of the minimization of the three maintenance immunosuppressive strategies, cyclosporine A (CsA) + azathioprine (AZA), CsA + mycophenolate mofetil (MMF), or CsA monotherapy in a cohort of transplant recipients.
All patients received induction therapy with antithymocyte/lymphocyte antibodies. At 11–24 months post-transplant, patients were randomized into three groups, CsA+AZA, CsA+MMF, and CsA monotherapy.
204 low immunological risk kidney transplant recipients
The primary outcome measured was the occurrence of biopsies for graft dysfunction and/or proteinuria. Secondary outcomes measured were biopsy-proven acute rejection, CsA nephrotoxicity episode, renal function, and patient and graft survival.
This is a rarely seen 10-year follow up of a French multicentre RCT randomising 204 kidney transplant recipients in a 1:1:2 fashion to CsA/MMF, CsA/AZA or CsA monotherapy. Low risk kidney transplant recipients who were on CsA/MMF with steroids withdrawn were randomised on average 14 months after transplantation. After the 36 month study visit, patients were followed up annually for an additional 7 years with the assigned immunosuppressive regimen being maintained in 70% of patients on CsA/AZA, 66% of patient on CsA/AZA and in 61% of patients on CsA monotherapy at 10 years. To achieve a power of 80%, 100 patients per arm were needed. When comparing the CsA monotherapy group with the 2 bitherapy groups at 36 months, there were no differences in terms of the number of biopsies performed for graft dysfunction (primary outcome), or the incidence of BPAR, CsA toxicity, or death-censored graft survival. At 10 years there was no difference in patient survival, graft survival, renal function or any of the other secondary outcomes between the three groups. Of note is that the study population was a low risk population with the donor age being <45 years, which limits the generalizability of these results.
Clinicaltrials.gov - NCT980654