A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
- Conditions
- AnemiaRenal Insufficiency, Chronic
- Interventions
- Registration Number
- NCT03350321
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
- 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
- Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization
- Mean of the last 2 central laboratory Hb levels 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) and the last measurements must be taken within 14 days prior to randomization
- 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)
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 Hb level Baseline and up to 52 weeks Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once Up to 52 weeks Change in Hb level Baseline and up to 52 weeks 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 treatmentRate of rise in Hb (Hemoglobin) level (g/dL/week) Up to 4 weeks Proportion 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 mean hemoglobin level is in the target range From week 30 to 36 Proportion of subjects whose mean hemoglobin level is above the target range From week 30 to 36 Proportion of subjects whose mean hemoglobin level is below the target range From week 30 to 36 Proportion of subjects with hemoglobin levels in the target range Up to 52 weeks Proportion of subjects with hemoglobin levels above the target range Up to 52 weeks Proportion of subjects with hemoglobin levels below 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)
Number of participants with serious adverse events Up to 52 weeks Maximum concentration (Cmax) At baseline, week 12, week 24 and week 52 Area under the concentration-time curve (AUC) At baseline, week 12, week 24 and week 52 EPO (Erythropoietin) serum concentration At baseline, week 12, week 24 and week 52
Trial Locations
- Locations (61)
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
St.Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Seikeikai New Tokyo Heart Clinic
🇯🇵Matsudo, Chiba, Japan
Toshima Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
KenAiKai medical corporation Akiyama clinic
🇯🇵Takamatsu, Kagawa, Japan
National hospital Organization Mito Medical Center
🇯🇵Higashiibaraki, Ibaraki, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Koukan Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Osaka Red Cross Hospital
🇯🇵Osaka, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Nara Prefecture General Medical Center
🇯🇵Nara, Japan
Nippon Life Hospital
🇯🇵Osaka, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Showa University Koto Toyosu Hospital
🇯🇵Koto-ku, Tokyo, Japan
Kainan Hospital
🇯🇵Yatomi, Aichi, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Saiseikai Matsuyama Hospital
🇯🇵Matsuyama, Ehime, Japan
Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
National Fukuoka-Higashi Medical Center
🇯🇵Koga, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Mazda Hospital of Mazda Motor Corporation
🇯🇵Aki-gun, Hiroshima, Japan
Matsunami Health Promotion Clinic
🇯🇵Hashima-gun, Gifu, Japan
Gifu Prefectural Tajimi Hospital
🇯🇵Tajimi, Gifu, Japan
Nippon Kokan Fukuyama Hospital
🇯🇵Fukuyama, Hiroshima, Japan
Teine Keijinkai Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Mito Kyodo General Hospital
🇯🇵Mito, Ibaraki, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama, Kanagawa, Japan
National Hospital Organization Kobe Medical Center
🇯🇵Kobe, Hyogo, Japan
Ikeda Hospital
🇯🇵Kanoya, Kagoshima, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Kanagawa, Japan
Arao Municipal Hospital
🇯🇵Arao, Kumamoto, Japan
Kumamoto Rosai Hospital
🇯🇵Yatsushiro, Kumamoto, Japan
JCHO Yokkaichi Hazu Medical Center
🇯🇵Yokkaichi, Mie, Japan
Uji-Tokushukai Medical Center
🇯🇵Uji, Kyoto, Japan
Japanese Red Cross Ishinomaki Hospital
🇯🇵Ishinomaki, Miyagi, Japan
Asama Nanroku Komoro Medical Center
🇯🇵Komoro, Nagano, Japan
Niigata Prefectural Shibata Hospital
🇯🇵Shibata, Niigata, Japan
Okinawa prefectural Chubu Hospital
🇯🇵Uruma, Okinawa, Japan
Osaka Pref. Saiseikai Tondabayashi Hospital
🇯🇵Tondabayashi, Osaka, Japan
Kitasato University Medical Center
🇯🇵Kitamoto, Saitama, Japan
Osaka Saiseikai Senri Hospital
🇯🇵Suita, Osaka, Japan
Iwata City Hospital
🇯🇵Iwata, Shizuoka, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanashi, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Asahi University Hospital
🇯🇵Gifu, Japan
National Hospital Organization Kochi National Hospital
🇯🇵Kochi, Japan
Japanese Red Cross Oita Hospital
🇯🇵Oita, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Kitano Hospital
🇯🇵Osaka, Japan
Chibune Clinic
🇯🇵Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Social Corporation Keigakukai Minamiosaka Hospital
🇯🇵Osaka, Japan
Shizuoka Saiseikai General Hospital
🇯🇵Shizuoka, Japan
Suruga Clinic
🇯🇵Shizuoka, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan