Trial Condition(s):
A study of Molidustat for correction of renal anemia in dialysis subjects (MIYABI HD-C)
The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)
- Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly - Body weight > 40 and ≤ 160 kg at screening - Male or female subject ≥ 20 years of age at screening - At least one kidney - Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol - Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment - Ferritin ≥ 50 ng/mL 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 and poorly controlled arterial hypertension (defined as systolic BP≥ 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)
Locations | Status | ||
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Locations Itami Kidney Clinic Noboribetsu, Japan, 059-0026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ishikari Hospital Ishikari, Japan, 061-3213 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Japanese Red Cross Ishinomaki Hospital Ishinomaki, Japan, 986-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Tokiwa Clinic Totte, Japan, 302-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kikuchi Medical Clinic Tsukuba, Japan, 305-0861 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Asahikawa-Kosei General Hospital Asahikawa, Japan, 078-8211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Souen Central Hospital Sapporo, Japan, 060-0008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Yamagata Tokushukai Hospital Yamagata, Japan, 990-0834 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Tsuchiura Beryl Clinic Tsuchiura, Japan, 300-0062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ohmiya Chuo General Hospital Saitama, Japan, 331-8711 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Matsunami General Hospital Hashima-gun, Japan, 501-6062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Toyonaka Keijinkai Clinic Toyonaka, Japan, 560-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Takasago Seibu Hospital Takasago, Japan, 676-0812 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Japanese Red Cross Koga Hospital Koga, Japan, 306-0014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Houshikai Kano hospital Kasuya-gun, Japan, 811-0120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fukuoka Renal Clinic Fukuoka, Japan, 810-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Medical corporation association Shunshin-kai Inage hospital Chiba, Japan, 263-0043 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Iida Hospital Iida, Japan, 395-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kodaira Kitaguchi Clinic Kodaira, Japan, 187-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
A single arm, multicenter study to investigate the efficacy and safety of oral molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1