Trial Condition(s):
Anemia, Renal Insufficiency, Chronic
Maintenance treatment of renal anemia in dialysis subjects (MIYABI HD-M)
Bayer Identifier:
19352
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Asahikawa-Kosei General Hospital Asahikawa, Japan, 078-8211 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Itami Kidney Clinic Noboribetsu, Japan, 059-0026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ishikari Hospital Ishikari, Japan, 061-3213 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Souen Central Hospital Sapporo, Japan, 060-0008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seisuikai Yoshioka Mahoroba Clinic Kurokawa-gun, Japan, 981-3632 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eijinkai Hospital Osaki, Japan, 989-6117 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yamagata Tokushukai Hospital Yamagata, Japan, 990-0834 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tsuchiura Beryl Clinic Tsuchiura, Japan, 300-0062 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokiwa Clinic Totte, Japan, 302-0011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kikuchi Medical Clinic Tsukuba, Japan, 305-0861 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Koga Hospital Koga, Japan, 306-0014 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ibaraki Prefectural Central Hospital Kasama, Japan, 309-1793 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Todachuo General Hospital Toda, Japan, 335-0023 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saiyu Clinic Koshigaya, Japan, 343-0823 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Higashimatsuyamakohjin Clinic Higashimatsuyama, Japan, 355-0016 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kisarazu Clinic Kisarazu, Japan, 292-0805 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical corporation association Shunshin-kai Inage hospital Chiba, Japan, 263-0043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shinkashiwa Clinic Kashiwa, Japan, 277-0084 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kodaira Kitaguchi Clinic Kodaira, Japan, 187-0001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chigasaki Central Clinic Chigasaki, Japan, 253-0052 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yokohama Jin Clinic Yokohama, Japan, 224-0032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Eda Clinic Yokohama, Japan, 225-0015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kaminagaya Saitou Clinic Yokohama, Japan, 233-0013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Honatsugi Medical Clinic Atsugi, Japan, 243-0013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sabae kidney Clinic Sabae, Japan, 916-0044 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Maruko Central Hospital Ueda, Japan, 386-0405 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iida Hospital Iida, Japan, 395-8505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Matsumoto City Hospital Matsumoto, Japan, 390-1401 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kanno Dialysis & Vascular Access Clinic Matsumoto, Japan, 390-0821 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Corporation Suzukihinyoukika Nagano, Japan, 380-0904 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hakuyoukai Medical corporation Hakuyoukai Hospital Nagoya, Japan, 465-0025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toyonaka Keijinkai Clinic Toyonaka, Japan, 560-0004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chibune Clinic Osaka, Japan, 555-0001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Akagaki Clinic Osaka, Japan, 543-0052 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nishi Shinryosho Osaka, Japan, 552-0007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Arisawa General Hospital Hirakata, Japan, 573-1195 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saint Hill Hospital Ube, Japan, 755-0155 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kaisei Hospital Sakaide, Japan, 762-0007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kuwajima Clinic Niihama, Japan, 792-0812 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Houshikai Kano hospital Kasuya-gun, Japan, 811-0120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saiseikai Yahata General Hospital Kitakyushu, Japan, 805-0050 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ikeda Vascular Access Nephrology Dialysis Fukuoka, Japan, 810-0012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oohashi internal medicine circulatory Clinic Fukuoka, Japan, 815-0038 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nagasaki Kidney Hospital Nagasaki, Japan, 850-0032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ueki Imafuji Clinic Kumamoto, Japan, 861-0135 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Public Central Hospital of Matto Ishikawa Hakusan, Japan, 924-8588 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Koizumi Cardiology Medical Clinic Chitose, Japan, 066-0062 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sanshikai Toho Hospital Midori, Japan, 379-2311 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hanyu General Hospital Hanyu, Japan, 348-0045 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iwatsuki-minami Hospital Saitama, Japan, 339-0033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hachioji Azumacho Clinic Hachioji, Japan, 192-0082 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toshiba Rinkan Hospital Sagamihara, Japan, 252-0385 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Primary Outcome
- The mean Hb level during the evaluation periodTimeframe: From week 33 to 36
- The change in mean Hb level during the evaluation period from baselineTimeframe: Baseline and week 33 to 36
Secondary Outcome
- Responder rate: proportion of responders among the subjectsResponder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatmentTimeframe: From week 33 to 36
- Proportion of subjects who meet each component of the responseResponse: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatmentTimeframe: From week 33 to 36
- Hb levelTimeframe: Up to 52 weeks
- Change in Hb levelTimeframe: Baseline and up to 52 weeks
- Proportion of subjects whose mean hemoglobin level is in the target rangeTimeframe: From week 33 to 36
- Proportion of subjects whose mean hemoglobin level is above the target rangeTimeframe: From week 33 to 36
- Proportion of subjects whose mean hemoglobin level is below the target rangeTimeframe: From week 33 to 36
- Proportion of subjects with hemoglobin levels in the target rangeTimeframe: Up to 52 weeks
- Proportion of subjects with hemoglobin levels above the target rangeTimeframe: Up to 52 weeks
- Proportion of subjects with hemoglobin levels below the target rangeTimeframe: Up to 52 weeks
- Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/weekDefined as change in Hb level / duration between two visits (weeks)Timeframe: Up to 52 weeks
- Number of participants with serious adverse eventsTimeframe: Up to 52 weeks
- Maximum concentration (Cmax)Timeframe: At baseline, week 8, week 24 and week 52
- Area under the concentration-time curve (AUC)Timeframe: At baseline, week 8, week 24 and week 52
- EPO (Erythropoietin) serum concentrationTimeframe: At baseline, week 8, week 24 and week 52
Additional Information
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