A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
- Conditions
- AnemiaRenal Insufficiency, Chronic
- Interventions
- Registration Number
- NCT03350347
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
- Have used the same ESA for 8 weeks prior to screening
- Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
- Body weight > 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- Not on dialysis and not expected to start dialysis during the study period
- Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week 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%
- 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 (blood pressure)≥ 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Molidustat (BAY85-3934) Molidustat (BAY85-3934) Molidustat group Darbepoetin alfa Darbepoetin alfa Darbepoetin alfa group
- Primary Outcome Measures
Name Time Method Mean Hb (Hemoglobin) level From week 30 to 36 Change in hemoglobin level from baseline to the average during the evaluation period Baseline and week 30 to 36
- Secondary Outcome Measures
Name Time Method Number of participants with serious adverse events Up to 52 weeks Proportion of subjects whose hemoglobin levels are below the target range Up to 52 weeks EPO (Erythropoietin) serum concentration of Molidustat At baseline, week 12, week 24 and week 52 Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period From week 30 to 36 Responder rate: proportion of responders among the subjects From week 30 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 30 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 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 hemoglobin levels are in the target range Up to 52 weeks Hb level Baseline and up to 52 weeks Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period From week 30 to 36 Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period From week 30 to 36 Change in Hb level Baseline and up to 52 weeks Maximum concentration (Cmax) of Molidustat At baseline, week 12, week 24 and week 52 Proportion of subjects whose hemoglobin levels are above the target range Up to 52 weeks Area under the concentration-time curve (AUC) of Molidustat At baseline, week 12, week 24 and week 52
Trial Locations
- Locations (59)
Matsunami Health Promotion Clinic
🇯🇵Hashima-gun, Gifu, Japan
Mazda Hospital of Mazda Motor Corporation
🇯🇵Aki-gun, Hiroshima, Japan
Higashihiroshima Medical Center
🇯🇵Higashihiroshima, Hiroshima, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Asama Nanroku Komoro Medical Center
🇯🇵Komoro, Nagano, Japan
Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Nippon Kokan Fukuyama Hospital
🇯🇵Fukuyama, Hiroshima, Japan
St.Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Koukan Clinic
🇯🇵Kawasaki, Kanagawa, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Iwata City Hospital
🇯🇵Iwata, Shizuoka, Japan
Teine Keijinkai Clinic
🇯🇵Sapporo, Hokkaido, Japan
Toshima Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Kitasato University Medical Center
🇯🇵Kitamoto, Saitama, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
Chibune Clinic
🇯🇵Osaka, Japan
Shizuoka Saiseikai General Hospital
🇯🇵Shizuoka, Japan
Social Corporation Keigakukai Minamiosaka Hospital
🇯🇵Osaka, Japan
Ikeda Hospital
🇯🇵Kanoya, Kagoshima, Japan
Arao Municipal Hospital
🇯🇵Arao, Kumamoto, Japan
JCHO Yokkaichi Hazu Medical Center
🇯🇵Yokkaichi, Mie, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Kanagawa, Japan
Osaka Pref. Saiseikai Tondabayashi Hospital
🇯🇵Tondabayashi, Osaka, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Osaka Red Cross Hospital
🇯🇵Osaka, Japan
Nippon Life Hospital
🇯🇵Osaka, Japan
Kainan Hospital
🇯🇵Yatomi, Aichi, Japan
Seikeikai New Tokyo Heart Clinic
🇯🇵Matsudo, Chiba, Japan
Saiseikai Matsuyama Hospital
🇯🇵Matsuyama, Ehime, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
National Fukuoka-Higashi Medical Center
🇯🇵Koga, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Mito Kyodo General Hospital
🇯🇵Mito, Ibaraki, Japan
Public Central Hospital of Matto Ishikawa
🇯🇵Hakusan, Ishikawa, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
National Hospital Organization Kobe Medical Center
🇯🇵Kobe, Hyogo, Japan
KenAiKai medical corporation Akiyama clinic
🇯🇵Takamatsu, Kagawa, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama, Kanagawa, Japan
Niigata Prefectural Shibata Hospital
🇯🇵Shibata, Niigata, Japan
Japanese Red Cross Ishinomaki Hospital
🇯🇵Ishinomaki, Miyagi, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanashi, Japan
R.I.A.C Naha City Hospital
🇯🇵Naha, Okinawa, Japan
Showa University Koto Toyosu Hospital
🇯🇵Koto-ku, Tokyo, Japan
Asahi University Hospital
🇯🇵Gifu, Japan
Japanese Red Cross Oita Hospital
🇯🇵Oita, Japan
Miyazaki Prefectural Miyazaki Hospital
🇯🇵Miyazaki, Japan
National Hospital Organization Kochi National Hospital
🇯🇵Kochi, Japan
Nara Prefecture General Medical Center
🇯🇵Nara, Japan
Kitano Hospital
🇯🇵Osaka, Japan
Yodogawa Christian Hospital
🇯🇵Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Suruga Clinic
🇯🇵Shizuoka, Japan