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Two‐year outcomes in de novo renal transplant recipients receiving everolimus‐facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study
Author(s) -
Berger Stefan P.,
Sommerer Claudia,
Witzke Oliver,
Tedesco Helio,
Chadban Steve,
Mulgaonkar Shamkant,
Qazi Yasir,
Fijter Johan W.,
Oppenheimer Federico,
Cruzado Josep M.,
Watarai Yoshihiko,
Massari Pablo,
Legendre Christophe,
Citterio Franco,
Henry Mitchell,
Srinivas Titte R.,
Vincenti Flavio,
Gutierrez Maria Pilar Hernandez,
Marti Ana Maria,
Bernhardt Peter,
Pascual Julio
Publication year - 2019
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15480
Subject(s) - medicine , calcineurin , everolimus , renal transplant , regimen , urology , mycophenolate , pharmacology , transplantation
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 m 2 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 m 2 ) in both arms. The incidence of de novo donor‐specific antibodies (dn DSA ) 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 dn DSA rates and significantly lower incidence of viral infections relative to standard‐of‐care up to 24 months. Clinicaltrials.gov number: NCT 01950819.