Trial Condition(s):
A study of Molidustat for treatment of renal anemia in peritoneal dialysis subjects (MIYABI PD)
19353
Not Available
Not Available
The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia
- Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period - Body weight > 40 and ≤ 160 kg at screening - Male or female subject ≥ 20 years of age at screening - At least one kidney - Subjects who meet one of the 1 or 2 following criteria -- Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 8.0 and < 11.0 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 -- Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and < 13.0 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 - Subjects who meet one of the 1 or 2 following criteria -- Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol -- Subjects pre treated with ESA at assignment: ---Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment ---Subject treated with ESA by IV or SC within 8 weeks prior to assignment ---Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment
- 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 | |
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Locations Fukushima Medical University Hospital Fukushima, Japan, 960-1295 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Niigata Prefectural Shibata Hospital Shibata, Japan, 957-8588 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Showa University Fujigaoka Hospital Yokohama, Japan, 227-8501 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fujisawa City Hospital Fujisawa, Japan, 251-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kainan Hospital Yatomi, Japan, 498-8502 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asahi University Hospital Gifu, Japan, 500-8523 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nara Prefecture General Medical Center Nara, Japan, 630-8581 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ehime Prefectural Central Hospital Matsuyama, Japan, 790-0024 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukuoka University Hospital Fukuoka, Japan, 814-0180 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations JCHO Kyushu Hospital Kitakyushu, Japan, 806-8501 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Fukuoka Hospital Fukuoka, Japan, 815-8555 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Oita Hospital Oita, Japan, 870-0033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Okinawa prefectural Chubu Hospital Uruma, Japan, 904-2293 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Elm Grove Clinic Sapporo, Japan, 003-0814 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tohoku Medical and Pharmaceutical University Hospital Sendai, Japan, 983-8512 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Niigata City General Hospital Niigata, Japan, 950-1197 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toranomon Hospital Kajigaya Kawasaki, Japan, 213-8587 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukui-ken Saiseikai Hospital Fukui, Japan, 918-8503 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kyoto Medical Center Kyoto, Japan, 612-8555 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fuchu Hospital Izumi, Japan, 594-0076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Beppu Medical Center Beppu, Japan, 874-0011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
An open-label, multicenter study to investigate the efficacy and safety of oral molidustat in peritoneal dialysis subjects with renal anemia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1