Open AccessEfficacy and Safety of Molidustat for Anemia in ESA-Naive Nondialysis Patients: A Randomized, Phase 3 Trial
Author(s) -
Hiroyasu Yamamoto,
Kiyoshi Nobori,
Yoshinobu Matsuda,
Yasuhiko Hayashi,
Takanori Hayasaki,
Tadao Akizawa
Publication year - 2021
Publication title -
american journal of nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.394
H-Index - 85
eISSN - 1421-9670
pISSN - 0250-8095
DOI - 10.1159/000518071
Subject(s) - medicine , darbepoetin alfa , anemia , erythropoietin , kidney disease , adverse effect , randomized controlled trial , dialysis , hemoglobin , surgery , gastroenterology
Molidustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that predominantly induces renal production of erythropoietin (EPO). Molidustat was evaluated for the treatment of anemia associated with chronic kidney disease (CKD) in the "Molidustat Once Daily Improves Renal Anemia by Inducing EPO" (MIYABI) program, which comprises 5 phase 3 clinical trials. The present MIYABI Non-Dialysis Correction (ND-C) study investigated the efficacy and safety of molidustat in Japanese patients with renal anemia who were not undergoing dialysis and were not receiving erythropoiesis-stimulating agent (ESA) treatment.