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

Watarai Y 1 , Danguilan R 2 , Casasola C 2 , Chang SS 3 , Ruangkanchanasetr P 4 , Kee T 5 Show all authors , Wong HS 6 , Kenmochi T 7 , Amante AJ 2 , Shu KH 8 , Ingsathit A 9 , Bernhardt P 10 , Hernandez-Gutierrez MP 10 , Han DJ 11 , Kim MS 12

Affiliations 

  • 1 Department of Transplant Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan
  • 2 Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines
  • 3 Department of Surgery, National Cheng Kung University College of Medicine and Hospital, Tainan, Taiwan
  • 4 Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand
  • 5 Department of Renal Medicine, Singapore General Hospital, Singapore, Singapore
  • 6 Department of Nephrology & Clinical Research Centre Hospital Selayang, Selangor Darul Ehsan, Batu Caves, Malaysia
  • 7 Department of Transplant Surgery, Fujita Health University Hospital, Toyoake, Japan
  • 8 Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
  • 9 Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • 10 Department of Research and Development, Novartis Pharma AG, Basel, Switzerland
  • 11 Department of General Surgery, Asan Medical Center, Seoul, Republic of Korea
  • 12 Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea
Clin Transplant, 2021 10;35(10):e14415.
PMID: 34216395 DOI: 10.1111/ctr.14415

Abstract

OBJECTIVE: 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) 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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