Trial Condition(s):
A study of Molidustat for correction of renal anemia in dialysis subjects (MIYABI HD-C)
19351
Not Available
Not Available
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 | |
---|---|---|
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