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Everolimus‐facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2‐year results from the subgroup analysis of the TRANSFORM study
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 transp...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9255374/ https://www.ncbi.nlm.nih.gov/pubmed/34216395 http://dx.doi.org/10.1111/ctr.14415 |
Sumario: | 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) < 50 ml/min/1.73 m(2) 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 m(2), P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m(2), 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). |
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