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 Change in hemoglobin level from baseline to the average during the evaluation period Baseline and week 30 to 36 Mean Hb (Hemoglobin) level From 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 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 treatmentResponder 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 treatmentHb 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 Proportion of subjects whose hemoglobin levels are in 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)
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)
Kainan Hospital
🇯🇵Yatomi, Aichi, Japan
Seikeikai New Tokyo Heart Clinic
🇯🇵Matsudo, Chiba, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Saiseikai Matsuyama Hospital
🇯🇵Matsuyama, Ehime, Japan
Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
National Fukuoka-Higashi Medical Center
🇯🇵Koga, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
St.Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Scroll for more (49 remaining)Kainan Hospital🇯🇵Yatomi, Aichi, Japan