Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study

Stefan P. Berger, Claudia Sommerer, Oliver Witzke, Helio Tedesco, Steve Chadban, Shamkant Mulgaonkar, Yasir Qazi, Johan W. De Fijter, Federico Oppenheimer, Josep M. Cruzado, Yoshihiko Watarai, Pablo Massari, Pietro Massari, Christophe Legendre, Franco Citterio, Mitchell Henry, Titte R. Srinivas, Flavio Vincenti, Maria Pilar Hernandez Gutierrez, Ana Maria MartiPeter Bernhardt, Julio Pascual

Research output: Contribution to journalArticle

33 Citations (Scopus)


TRANSFORM (TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen) was a 24-month, prospective, open-label trial in 2037 de novo renal transplant recipients randomized (1:1) within 24 hours of transplantation to receive everolimus (EVR) with reduced-exposure calcineurin inhibitor (EVR + rCNI) or mycophenolate with standard-exposure CNI. Consistent with previously reported 12-month findings, noninferiority of the EVR + rCNI regimen for the primary endpoint of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) <50 mL/min per 1.73 m2 was achieved at month 24 (47.9% vs 43.7%; difference = 4.2%; 95% confidence interval = −0.3, 8.7; P =.006). Mean eGFR was stable up to month 24 (52.6 vs 54.9 mL/min per 1.73 m2) in both arms. The incidence of de novo donor-specific antibodies (dnDSA) was lower in the EVR + rCNI arm (12.3% vs 17.6%) among on-treatment patients. Although discontinuation rates due to adverse events were higher with EVR + rCNI (27.2% vs 15.0%), rates of cytomegalovirus (2.8% vs 13.5%) and BK virus (5.8% vs 10.3%) infections were lower. Cytomegalovirus infection rates were significantly lower with EVR + rCNI even in the D+/R− high-risk group (P <.0001). In conclusion, the EVR + rCNI regimen offers comparable efficacy and graft function with low tBPAR and dnDSA rates and significantly lower incidence of viral infections relative to standard-of-care up to 24 months. number: NCT01950819.
Original languageEnglish
Pages (from-to)3018-3034
Number of pages17
JournalAmerican Journal of Transplantation
Publication statusPublished - 2019


  • Calcineurin Inhibitors
  • Everolimus
  • Female
  • Follow-Up Studies
  • Graft Rejection
  • Graft Survival
  • Humans
  • Immunosuppressive Agents
  • Kidney Failure, Chronic
  • Kidney Transplantation
  • Male
  • Middle Aged
  • Postoperative Complications
  • Prognosis
  • Prospective Studies
  • Risk Factors
  • Survival Rate
  • clinical research/practice
  • immunosuppressant - mechanistic target of rapamycin (mTOR)
  • immunosuppressant - mechanistic target of rapamycin: everolimus
  • immunosuppression/immune modulation
  • immunosuppressive regimens - minimization/withdrawal
  • kidney transplantation/nephrology
  • liver transplantation/hepatology


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