A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
MIYABI ND-M
A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)
1 other identifier
interventional
164
1 country
59
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2017
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2019
CompletedJanuary 29, 2021
January 1, 2021
1.6 years
November 19, 2017
January 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Hb (Hemoglobin) level
From week 30 to 36
Change in hemoglobin level from baseline to the average during the evaluation period
Baseline and week 30 to 36
Secondary Outcomes (15)
Responder rate: proportion of responders among the subjects
From week 30 to 36
Proportion of subjects who meet each component of the response
From week 30 to 36
Hb level
Baseline and up to 52 weeks
Change in Hb level
Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
From week 30 to 36
- +10 more secondary outcomes
Study Arms (2)
Molidustat (BAY85-3934)
EXPERIMENTALMolidustat group
Darbepoetin alfa
ACTIVE COMPARATORDarbepoetin alfa group
Interventions
Starting dose of 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response
Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response
Eligibility Criteria
You may qualify if:
- Subjects with estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73m\^2 (Chronic kidney disease \[CKD\] stages 3 to 5)
- Have used the same ESA for 8 weeks prior to screening
- Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
- Body weight \> 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- Not on dialysis and not expected to start dialysis during the study period
- Mean screening Hb level ≥ 10.0 and \< 13.0 g/dL (mean of all central laboratory Hb levels \[at least 2 measurements must be taken ≥ 2 days apart\] during the 8-week screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is \< 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
- Ferritin ≥ 100 ng/mL or Transferrin saturation ≥ 20%
You may not qualify if:
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization
- Sustained and poorly controlled arterial hypertension (defined as systolic BP (blood pressure)≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP \< 90mmHg) at randomization
- Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (59)
Kainan Hospital
Yatomi, Aichi-ken, 498-8502, Japan
Seikeikai New Tokyo Heart Clinic
Matsudo, Chiba, 271-0077, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026, Japan
Iizuka Hospital
Iizuka, Fukuoka, 820-8505, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508, Japan
National Fukuoka-Higashi Medical Center
Koga, Fukuoka, 811-3195, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
St.Mary's Hospital
Kurume, Fukuoka, 830-8543, Japan
Matsunami Health Promotion Clinic
Hashima-gun, Gifu, 501-6061, Japan
Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, 735-8585, Japan
Nippon Kokan Fukuyama Hospital
Fukuyama, Hiroshima, 721-0927, Japan
Higashihiroshima Medical Center
Higashihiroshima, Hiroshima, 739-0041, Japan
Teine Keijinkai Clinic
Sapporo, Hokkaido, 006-8555, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
National Hospital Organization Kobe Medical Center
Kobe, Hyōgo, 654-0155, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Public Central Hospital of Matto Ishikawa
Hakusan, Ishikawa-ken, 924-8588, Japan
KenAiKai medical corporation Akiyama clinic
Takamatsu, Kagawa-ken, 761-1701, Japan
Ikeda Hospital
Kanoya, Kagoshima-ken, 893-0024, Japan
Fujisawa City Hospital
Fujisawa, Kanagawa, 251-8550, Japan
Koukan Clinic
Kawasaki, Kanagawa, 210-0852, Japan
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8501, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, 238-8558, Japan
Arao Municipal Hospital
Arao, Kumamoto, 864-0041, Japan
JCHO Yokkaichi Hazu Medical Center
Yokkaichi, Mie-ken, 510-0016, Japan
Japanese Red Cross Ishinomaki Hospital
Ishinomaki, Miyagi, 986-8522, Japan
Asama Nanroku Komoro Medical Center
Komoro, Nagano, 384-8588, Japan
Niigata Prefectural Shibata Hospital
Shibata, Niigata, 957-8588, Japan
R.I.A.C Naha City Hospital
Naha, Okinawa, 902-8511, Japan
Osaka Pref. Saiseikai Tondabayashi Hospital
Tondabayashi, Osaka, 584-0082, Japan
Kitasato University Medical Center
Kitamoto, Saitama, 364-8501, Japan
Iwata City Hospital
Iwata, Shizuoka, 438-8550, Japan
Toshima Hospital
Itabashi-ku, Tokyo, 173-0015, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Showa University Koto Toyosu Hospital
Koto-ku, Tokyo, 135-8577, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
Fukui Prefectural Hospital
Fukui, 910-8526, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Asahi University Hospital
Gifu, 500-8523, Japan
National Hospital Organization Kochi National Hospital
Kochi, 780-8077, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, 880-8510, Japan
Nara Prefecture General Medical Center
Nara, 630-8581, Japan
Kitano Hospital
Osaka, 530-8480, Japan
Yodogawa Christian Hospital
Osaka, 533-0024, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
Nippon Life Hospital
Osaka, 550-0006, Japan
Chibune Clinic
Osaka, 555-0001, Japan
Osaka General Medical Center
Osaka, 558-8558, Japan
Social Corporation Keigakukai Minamiosaka Hospital
Osaka, 559-0012, Japan
Japanese Red Cross Oita Hospital
Ōita, 870-0033, Japan
Shizuoka Saiseikai General Hospital
Shizuoka, 422-8527, Japan
Suruga Clinic
Shizuoka, 424-0855, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Related Publications (3)
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.
PMID: 37095342DERIVEDNatale 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.
PMID: 36005278DERIVEDYamamoto 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.
PMID: 31203242DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2017
First Posted
November 22, 2017
Study Start
December 13, 2017
Primary Completion
July 5, 2019
Study Completion
November 28, 2019
Last Updated
January 29, 2021
Record last verified: 2021-01