Trial Condition(s):
Maintenance treatment of renal anemia in dialysis subjects (MIYABI HD-M)
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).
- 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
- 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
Locations | Status | ||
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Locations Asahikawa-Kosei General Hospital Asahikawa, Japan, 078-8211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Itami Kidney Clinic Noboribetsu, Japan, 059-0026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ishikari Hospital Ishikari, Japan, 061-3213 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Souen Central Hospital Sapporo, Japan, 060-0008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Seisuikai Yoshioka Mahoroba Clinic Kurokawa-gun, Japan, 981-3632 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Eijinkai Hospital Osaki, Japan, 989-6117 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Yamagata Tokushukai Hospital Yamagata, Japan, 990-0834 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tsuchiura Beryl Clinic Tsuchiura, Japan, 300-0062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tokiwa Clinic Totte, Japan, 302-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kikuchi Medical Clinic Tsukuba, Japan, 305-0861 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Japanese Red Cross Koga Hospital Koga, Japan, 306-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ibaraki Prefectural Central Hospital Kasama, Japan, 309-1793 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Todachuo General Hospital Toda, Japan, 335-0023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Saiyu Clinic Koshigaya, Japan, 343-0823 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Higashimatsuyamakohjin Clinic Higashimatsuyama, Japan, 355-0016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kisarazu Clinic Kisarazu, Japan, 292-0805 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medical corporation association Shunshin-kai Inage hospital Chiba, Japan, 263-0043 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Shinkashiwa Clinic Kashiwa, Japan, 277-0084 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kodaira Kitaguchi Clinic Kodaira, Japan, 187-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Chigasaki Central Clinic Chigasaki, Japan, 253-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Yokohama Jin Clinic Yokohama, Japan, 224-0032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Eda Clinic Yokohama, Japan, 225-0015 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kaminagaya Saitou Clinic Yokohama, Japan, 233-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Honatsugi Medical Clinic Atsugi, Japan, 243-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Sabae kidney Clinic Sabae, Japan, 916-0044 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Maruko Central Hospital Ueda, Japan, 386-0405 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Iida Hospital Iida, Japan, 395-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Matsumoto City Hospital Matsumoto, Japan, 390-1401 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kanno Dialysis & Vascular Access Clinic Matsumoto, Japan, 390-0821 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medical Corporation Suzukihinyoukika Nagano, Japan, 380-0904 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hakuyoukai Medical corporation Hakuyoukai Hospital Nagoya, Japan, 465-0025 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Toyonaka Keijinkai Clinic Toyonaka, Japan, 560-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Chibune Clinic Osaka, Japan, 555-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Akagaki Clinic Osaka, Japan, 543-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Nishi Shinryosho Osaka, Japan, 552-0007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Arisawa General Hospital Hirakata, Japan, 573-1195 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Saint Hill Hospital Ube, Japan, 755-0155 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kaisei Hospital Sakaide, Japan, 762-0007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kuwajima Clinic Niihama, Japan, 792-0812 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Houshikai Kano hospital Kasuya-gun, Japan, 811-0120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Saiseikai Yahata General Hospital Kitakyushu, Japan, 805-0050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ikeda Vascular Access Nephrology Dialysis Fukuoka, Japan, 810-0012 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Oohashi internal medicine circulatory Clinic Fukuoka, Japan, 815-0038 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Nagasaki Kidney Hospital Nagasaki, Japan, 850-0032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ueki Imafuji Clinic Kumamoto, Japan, 861-0135 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Public Central Hospital of Matto Ishikawa Hakusan, Japan, 924-8588 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Koizumi Cardiology Medical Clinic Chitose, Japan, 066-0062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Sanshikai Toho Hospital Midori, Japan, 379-2311 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hanyu General Hospital Hanyu, Japan, 348-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Iwatsuki-minami Hospital Saitama, Japan, 339-0033 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hachioji Azumacho Clinic Hachioji, Japan, 192-0082 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Toshiba Rinkan Hospital Sagamihara, Japan, 252-0385 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2