Molidustat for Japanese Patients With Renal Anemia Receiving Dialysis

Published on Jul 23, 2021in Kidney International Reports4.164
· DOI :10.1016/J.EKIR.2021.07.015
Tadao Akizawa65
Estimated H-index: 65
(Showa University),
Takashi Yamada2
Estimated H-index: 2
(Bayer)
+ 4 AuthorsHiroyasu Yamamoto20
Estimated H-index: 20
(Jikei University School of Medicine)
Sources
Abstract
Introduction null Molidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for renal anemia treatment, was evaluated in 5 phase 3 studies (MIYABI program). We report the results of the MIYABI hemodialysis-maintenance study. null null null Methods null This 52-week, randomized, double-blinded, double-dummy study compared the efficacy and safety of molidustat and darbepoetin in Japanese patients receiving hemodialysis and erythropoiesis-stimulating agents. Molidustat (starting dose: 75 mg/day) and darbepoetin were titrated to maintain hemoglobin (Hb) levels in the target range (≥10.0 and  null null null Results null Overall, 229 patients were randomized (molidustat, n = 153; darbepoetin, n = 76). Baseline characteristics were well balanced. Mean baseline Hb level was 10.8 g/dl. Mean (95% confidence interval [CI]) for mean Hb levels during the evaluation period were within the target range in both groups (molidustat: 10.63 [10.42–10.84] g/dl; darbepoetin: 10.77 [10.59–10.95] g/dl). Least-squares mean (95% CI) change in mean Hb level during the evaluation period from baseline was –0.14 (–0.37 to 0.09) g/dl for molidustat and –0.07 (–0.30 to 0.16) g/dl for darbepoetin; molidustat was noninferior to darbepoetin (least-squares mean difference [95% CI] [molidustat–darbepoetin]: –0.13 [–0.46 to 0.19] g/dl), based on a noninferiority margin of 1.0 g/dl. In line with published literature, and as expected in this patient population, most participants had ≥1 treatment-emergent adverse event. null null null Conclusion null Molidustat maintained Hb levels throughout the trial in patients receiving dialysis and previously treated with erythropoiesis-stimulating agents, and was noninferior to darbepoetin.
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Introduction New medications for anaemia associated with chronic kidney disease (CKD) are desirable, owing to the limitations of erythropoiesis-stimulating agents (ESAs), the current standard of care. Molidustat is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates erythropoietin production, predominately in the kidney. We report methodological details of three phase III trials, named MolIdustat once dailY improves renal Anaemia By Inducing erythropoietin (MIYABI), des...
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#1Iain C. Macdougall (University of Cambridge)H-Index: 82
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