Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study

Yoshihiko WataraiRomina DanguilanConcesa CasasolaShen Shin ChangPrajej RuangkanchanasetrTerence KeeHin Seng WongTakashi KenmochiAngel Joaquin AmanteKuo Hsiung ShuAtiporn IngsathitPeter BernhardtMaria Pilar Hernandez-GutierrezDuck Jong HanMyoung Soo KimRamathibodi HospitalFujita Health University HospitalNational Kidney and Transplant Institute PhilippinesAsan Medical CenterSingapore General HospitalJapanese Red Cross Nagoya Daini HospitalYonsei University College of MedicineNovartis International AGPhramongkutklao College of MedicineVeterans General Hospital-Taichung TaiwanNational Cheng Kung University College of Medicine2022-08-042022-08-042021-10-01Clinical Transplantation. Vol.35, No.10 (2021)13990012090200632-s2.0-85115321900https://repository.li.mahidol.ac.th/handle/123456789/77813Objective: We analyzed the efficacy and safety of an everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard-exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study. Methods: In this 24-month, open-label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids. Results: Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2 or treated biopsy-proven acute rejection (27.0% vs. 29.2%, P =.011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2 vs. 66.3 ml/min/1.73 m2, P =.0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m2, P =.0582). Overall incidence of adverse events was comparable. BK virus (4.4% vs. 12.1%) and cytomegalovirus (4.4% vs. 13.4%) infections were significantly lower in the EVR+rCNI arm. Conclusion: This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819).Mahidol UniversityMedicineEverolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM studyArticleSCOPUS10.1111/ctr.14415