Maintenance Treatment of Renal Anemia in Dialysis Subjects
- Conditions
- Renal Insufficiency, ChronicAnemia
- Interventions
- Drug: Placebo of Molidustat (BAY85-3934)Drug: Placebo of Darbepoetin alfa
- Registration Number
- NCT03543657
- Lead Sponsor
- Bayer
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darbepoetin alfa group Placebo of Molidustat (BAY85-3934) Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa. Molidustat group Molidustat (BAY85-3934) Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo. Molidustat group Placebo of Darbepoetin alfa Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo. Darbepoetin alfa group Darbepoetin alfa Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.
- Primary Outcome Measures
Name Time Method The mean Hb level during the evaluation period From week 33 to 36 The change in mean Hb level during the evaluation period from baseline Baseline and week 33 to 36
- Secondary Outcome Measures
Name Time Method Proportion of subjects whose mean hemoglobin level is in the target range From week 33 to 36 Change in Hb level Baseline and up to 52 weeks Proportion of subjects with hemoglobin levels in the target range Up to 52 weeks Maximum concentration (Cmax) At baseline, week 8, week 24 and week 52 Area under the concentration-time curve (AUC) At baseline, week 8, week 24 and week 52 Hb level Up to 52 weeks Proportion of subjects with hemoglobin levels above the target range Up to 52 weeks Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week Up to 52 weeks Defined as change in Hb level / duration between two visits (weeks)
Proportion of subjects whose mean hemoglobin level is below the target range From week 33 to 36 Proportion of subjects with hemoglobin levels below the target range Up to 52 weeks Number of participants with serious adverse events Up to 52 weeks EPO (Erythropoietin) serum concentration At baseline, week 8, week 24 and week 52 Responder rate: proportion of responders among the subjects From week 33 to 36 Responder 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 treatmentProportion of subjects who meet each component of the response From week 33 to 36 Response:
(i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatmentProportion of subjects whose mean hemoglobin level is above the target range From week 33 to 36
Trial Locations
- Locations (53)
Chibune Clinic
🇯🇵Osaka, Japan
Maruko Central Hospital
🇯🇵Ueda, Nagano, Japan
Houshikai Kano hospital
🇯🇵Kasuya-gun, Fukuoka, Japan
Hakuyoukai Medical corporation Hakuyoukai Hospital
🇯🇵Nagoya, Aichi, Japan
Kisarazu Clinic
🇯🇵Kisarazu, Chiba, Japan
Koizumi Cardiology Medical Clinic
🇯🇵Chitose, Hokkaido, Japan
Saiseikai Yahata General Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Sanshikai Toho Hospital
🇯🇵Midori, Gunma, Japan
Asahikawa-Kosei General Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Ishikari Hospital
🇯🇵Ishikari, Hokkaido, Japan
Itami Kidney Clinic
🇯🇵Noboribetsu, Hokkaido, Japan
Souen Central Hospital
🇯🇵Sapporo, Hokkaido, Japan
Japanese Red Cross Koga Hospital
🇯🇵Koga, Ibaraki, Japan
Tokiwa Clinic
🇯🇵Totte, Ibaraki, Japan
Public Central Hospital of Matto Ishikawa
🇯🇵Hakusan, Ishikawa, Japan
Honatsugi Medical Clinic
🇯🇵Atsugi, Kanagawa, Japan
Toshiba Rinkan Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Yokohama Jin Clinic
🇯🇵Yokohama, Kanagawa, Japan
Arisawa General Hospital
🇯🇵Hirakata, Osaka, Japan
Kodaira Kitaguchi Clinic
🇯🇵Kodaira, Tokyo, Japan
Eda Clinic
🇯🇵Yokohama, Kanagawa, Japan
Kaminagaya Saitou Clinic
🇯🇵Yokohama, Kanagawa, Japan
Medical Corporation Suzukihinyoukika
🇯🇵Nagano, Japan
Seisuikai Yoshioka Mahoroba Clinic
🇯🇵Kurokawa-gun, Miyagi, Japan
Eijinkai Hospital
🇯🇵Osaki, Miyagi, Japan
Iida Hospital
🇯🇵Iida, Nagano, Japan
Toyonaka Keijinkai Clinic
🇯🇵Toyonaka, Osaka, Japan
Hanyu General Hospital
🇯🇵Hanyu, Saitama, Japan
Medical corporation association Shunshin-kai Inage hospital
🇯🇵Chiba, Japan
Ueki Imafuji Clinic
🇯🇵Kumamoto, Japan
Nagasaki Kidney Hospital
🇯🇵Nagasaki, Japan
Kanno Dialysis & Vascular Access Clinic
🇯🇵Matsumoto, Nagano, Japan
Higashimatsuyamakohjin Clinic
🇯🇵Higashimatsuyama, Saitama, Japan
Saint Hill Hospital
🇯🇵Ube, Yamaguchi, Japan
Saiyu Clinic
🇯🇵Koshigaya, Saitama, Japan
Hachioji Azumacho Clinic
🇯🇵Hachioji, Tokyo, Japan
Ikeda Vascular Access Nephrology Dialysis
🇯🇵Fukuoka, Japan
Oohashi internal medicine circulatory Clinic
🇯🇵Fukuoka, Japan
Akagaki Clinic
🇯🇵Osaka, Japan
Nishi Shinryosho
🇯🇵Osaka, Japan
Iwatsuki-minami Hospital
🇯🇵Saitama, Japan
Yamagata Tokushukai Hospital
🇯🇵Yamagata, Japan
Shinkashiwa Clinic
🇯🇵Kashiwa, Chiba, Japan
Kuwajima Clinic
🇯🇵Niihama, Ehime, Japan
Todachuo General Hospital
🇯🇵Toda, Saitama, Japan
Tsuchiura Beryl Clinic
🇯🇵Tsuchiura, Ibaraki, Japan
Kikuchi Medical Clinic
🇯🇵Tsukuba, Ibaraki, Japan
Kaisei Hospital
🇯🇵Sakaide, Kagawa, Japan
Chigasaki Central Clinic
🇯🇵Chigasaki, Kanagawa, Japan
Matsumoto City Hospital
🇯🇵Matsumoto, Nagano, Japan
Sabae kidney Clinic
🇯🇵Sabae, Fukui, Japan
Ibaraki Prefectural Central Hospital
🇯🇵Kasama, Ibaraki, Japan
Mito Kyodo General Hospital
🇯🇵Mito, Ibaraki, Japan