Maintenance Treatment of Renal Anemia in Dialysis Subjects
MIYABI HD-M
A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)
1 other identifier
interventional
229
1 country
53
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are 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 Jun 2018
53 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
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedStudy Start
First participant enrolled
June 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2019
CompletedJanuary 29, 2021
January 1, 2021
1.1 years
May 22, 2018
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
The mean Hb level during the evaluation period
From week 33 to 36
The change in mean Hb level during the evaluation period from baseline
Baseline and week 33 to 36
Secondary Outcomes (15)
Responder rate: proportion of responders among the subjects
From week 33 to 36
Proportion of subjects who meet each component of the response
From week 33 to 36
Hb level
Up to 52 weeks
Change in Hb level
Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin level is in the target range
From week 33 to 36
- +10 more secondary outcomes
Study Arms (2)
Molidustat group
EXPERIMENTALSubjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.
Darbepoetin alfa group
ACTIVE COMPARATORSubjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.
Interventions
Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).
Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.
Eligibility Criteria
You may qualify if:
- Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
- Body weight (after dialysis) \> 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- At least one kidney
- Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
- Mean screening Hb level ≥ 9.5 and \< 12.0 g/dL (mean of all central laboratory Hb levels before dialysis \[at least 2 measurements must be taken ≥ 2 days apart\] during the 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% at screening
- Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) at screening
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, 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 agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (53)
Hakuyoukai Medical corporation Hakuyoukai Hospital
Nagoya, Aichi-ken, 465-0025, Japan
Shinkashiwa Clinic
Kashiwa, Chiba, 277-0084, Japan
Kisarazu Clinic
Kisarazu, Chiba, 292-0805, Japan
Kuwajima Clinic
Niihama, Ehime, 792-0812, Japan
Sabae kidney Clinic
Sabae, Fukui, 916-0044, Japan
Houshikai Kano hospital
Kasuya-gun, Fukuoka, 811-0120, Japan
Saiseikai Yahata General Hospital
Kitakyushu, Fukuoka, 805-0050, Japan
Sanshikai Toho Hospital
Midori, Gunma, 379-2311, Japan
Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, 078-8211, Japan
Koizumi Cardiology Medical Clinic
Chitose, Hokkaido, 066-0062, Japan
Ishikari Hospital
Ishikari, Hokkaido, 061-3213, Japan
Itami Kidney Clinic
Noboribetsu, Hokkaido, 059-0026, Japan
Souen Central Hospital
Sapporo, Hokkaido, 060-0008, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 309-1793, Japan
Japanese Red Cross Koga Hospital
Koga, Ibaraki, 306-0014, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Tokiwa Clinic
Totte, Ibaraki, 302-0011, Japan
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, 300-0062, Japan
Kikuchi Medical Clinic
Tsukuba, Ibaraki, 305-0861, Japan
Public Central Hospital of Matto Ishikawa
Hakusan, Ishikawa-ken, 924-8588, Japan
Kaisei Hospital
Sakaidechō, Kagawa-ken, 762-0007, Japan
Honatsugi Medical Clinic
Atsugi, Kanagawa, 243-0013, Japan
Chigasaki Central Clinic
Chigasaki, Kanagawa, 253-0052, Japan
Toshiba Rinkan Hospital
Sagamihara, Kanagawa, 252-0385, Japan
Yokohama Jin Clinic
Yokohama, Kanagawa, 224-0032, Japan
Eda Clinic
Yokohama, Kanagawa, 225-0015, Japan
Kaminagaya Saitou Clinic
Yokohama, Kanagawa, 233-0013, Japan
Seisuikai Yoshioka Mahoroba Clinic
Kurokawa-gun, Miyagi, 981-3632, Japan
Eijinkai Hospital
Ōsaki, Miyagi, 989-6117, Japan
Iida Hospital
Iida, Nagano, 395-8505, Japan
Kanno Dialysis & Vascular Access Clinic
Matsumoto, Nagano, 390-0821, Japan
Matsumoto City Hospital
Matsumoto, Nagano, 390-1401, Japan
Maruko Central Hospital
Ueda, Nagano, 386-0405, Japan
Arisawa General Hospital
Hirakata, Osaka, 573-1195, Japan
Toyonaka Keijinkai Clinic
Toyonaka, Osaka, 560-0004, Japan
Hanyu General Hospital
Hanyū, Saitama, 348-0045, Japan
Higashimatsuyamakohjin Clinic
Higashi-Matsuyama, Saitama, 355-0016, Japan
Saiyu Clinic
Koshigaya, Saitama, 343-0823, Japan
Todachuo General Hospital
Toda, Saitama, 335-0023, Japan
Hachioji Azumacho Clinic
Hachiōji, Tokyo, 192-0082, Japan
Kodaira Kitaguchi Clinic
Kodaira, Tokyo, 187-0001, Japan
Saint Hill Hospital
Ube, Yamaguchi, 755-0155, Japan
Medical corporation association Shunshin-kai Inage hospital
Chiba, 263-0043, Japan
Ikeda Vascular Access Nephrology Dialysis
Fukuoka, 810-0012, Japan
Oohashi internal medicine circulatory Clinic
Fukuoka, 815-0038, Japan
Ueki Imafuji Clinic
Kumamoto, 861-0135, Japan
Medical Corporation Suzukihinyoukika
Nagano, 380-0904, Japan
Nagasaki Kidney Hospital
Nagasaki, 850-0032, Japan
Akagaki Clinic
Osaka, 543-0052, Japan
Nishi Shinryosho
Osaka, 552-0007, Japan
Chibune Clinic
Osaka, 555-0001, Japan
Iwatsuki-minami Hospital
Saitama, 339-0033, Japan
Yamagata Tokushukai Hospital
Yamagata, 990-0834, Japan
Related Publications (2)
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.
PMID: 36005278DERIVEDAkizawa T, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Yamamoto H. Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies. BMJ Open. 2019 Jun 14;9(6):e026602. doi: 10.1136/bmjopen-2018-026602.
PMID: 31203241DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 1, 2018
Study Start
June 23, 2018
Primary Completion
August 7, 2019
Study Completion
December 24, 2019
Last Updated
January 29, 2021
Record last verified: 2021-01