Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Maintenance treatment of renal anemia in dialysis subjects (MIYABI HD-M)

Bayer Identifier:

19352

ClinicalTrials.gov Identifier:

NCT03543657

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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).

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
229
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Asahikawa-Kosei General Hospital

Asahikawa, Japan, 078-8211

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Itami Kidney Clinic

Noboribetsu, Japan, 059-0026

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Ishikari Hospital

Ishikari, Japan, 061-3213

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Souen Central Hospital

Sapporo, Japan, 060-0008

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Seisuikai Yoshioka Mahoroba Clinic

Kurokawa-gun, Japan, 981-3632

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Eijinkai Hospital

Osaki, Japan, 989-6117

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Yamagata Tokushukai Hospital

Yamagata, Japan, 990-0834

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Tsuchiura Beryl Clinic

Tsuchiura, Japan, 300-0062

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Tokiwa Clinic

Totte, Japan, 302-0011

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Kikuchi Medical Clinic

Tsukuba, Japan, 305-0861

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Mito Kyodo General Hospital

Mito, Japan, 310-0015

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Japanese Red Cross Koga Hospital

Koga, Japan, 306-0014

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Ibaraki Prefectural Central Hospital

Kasama, Japan, 309-1793

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Todachuo General Hospital

Toda, Japan, 335-0023

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Saiyu Clinic

Koshigaya, Japan, 343-0823

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Higashimatsuyamakohjin Clinic

Higashimatsuyama, Japan, 355-0016

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Kisarazu Clinic

Kisarazu, Japan, 292-0805

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Medical corporation association Shunshin-kai Inage hospital

Chiba, Japan, 263-0043

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Shinkashiwa Clinic

Kashiwa, Japan, 277-0084

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Kodaira Kitaguchi Clinic

Kodaira, Japan, 187-0001

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Chigasaki Central Clinic

Chigasaki, Japan, 253-0052

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Yokohama Jin Clinic

Yokohama, Japan, 224-0032

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Eda Clinic

Yokohama, Japan, 225-0015

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Kaminagaya Saitou Clinic

Yokohama, Japan, 233-0013

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Honatsugi Medical Clinic

Atsugi, Japan, 243-0013

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Sabae kidney Clinic

Sabae, Japan, 916-0044

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Maruko Central Hospital

Ueda, Japan, 386-0405

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Iida Hospital

Iida, Japan, 395-8505

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Matsumoto City Hospital

Matsumoto, Japan, 390-1401

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Kanno Dialysis & Vascular Access Clinic

Matsumoto, Japan, 390-0821

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Medical Corporation Suzukihinyoukika

Nagano, Japan, 380-0904

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Hakuyoukai Medical corporation Hakuyoukai Hospital

Nagoya, Japan, 465-0025

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Toyonaka Keijinkai Clinic

Toyonaka, Japan, 560-0004

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Chibune Clinic

Osaka, Japan, 555-0001

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Akagaki Clinic

Osaka, Japan, 543-0052

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Nishi Shinryosho

Osaka, Japan, 552-0007

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Arisawa General Hospital

Hirakata, Japan, 573-1195

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Saint Hill Hospital

Ube, Japan, 755-0155

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Kaisei Hospital

Sakaide, Japan, 762-0007

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Kuwajima Clinic

Niihama, Japan, 792-0812

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Houshikai Kano hospital

Kasuya-gun, Japan, 811-0120

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Saiseikai Yahata General Hospital

Kitakyushu, Japan, 805-0050

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Ikeda Vascular Access Nephrology Dialysis

Fukuoka, Japan, 810-0012

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Oohashi internal medicine circulatory Clinic

Fukuoka, Japan, 815-0038

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Nagasaki Kidney Hospital

Nagasaki, Japan, 850-0032

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Ueki Imafuji Clinic

Kumamoto, Japan, 861-0135

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Public Central Hospital of Matto Ishikawa

Hakusan, Japan, 924-8588

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Koizumi Cardiology Medical Clinic

Chitose, Japan, 066-0062

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Sanshikai Toho Hospital

Midori, Japan, 379-2311

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Hanyu General Hospital

Hanyu, Japan, 348-0045

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Iwatsuki-minami Hospital

Saitama, Japan, 339-0033

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Hachioji Azumacho Clinic

Hachioji, Japan, 192-0082

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Toshiba Rinkan Hospital

Sagamihara, Japan, 252-0385

Trial Design