drugset / Trial / NCT03350347
A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)
Timeline
- Start
- 2017-12-13
- Primary completion
- 2019-07-05
- Completion
- 2019-11-28
Publications
- Yamamoto H, Yamada T, Miyazaki K, Yamashita T, Kato T, Ohara K, Nakamura Y, Akizawa T. Treatment satisfaction with molidustat in CKD-related anemia in non-dialysis patients: a post-hoc analysis of two clinical trials. Clin Exp Nephrol. 2023 Aug;27(8):651-659. doi: 10.1007/s10157-023-02353-x. Epub 2023 Apr 24.
- Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Yamamoto H, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Akizawa T. Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies. BMJ Open. 2019 Jun 14;9(6):e026704. doi: 10.1136/bmjopen-2018-026704.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | — | — |
| Subject | Molidustat | Small molecule | 25 mg | Oral |
| Subject | Molidustat | Small molecule | 50 mg | Oral |