A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects
- Conditions
- AnemiaRenal Insufficiency, Chronic
- Interventions
- Registration Number
- NCT03418168
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
-
Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period
-
Body weight > 40 and ≤ 160 kg at screening
-
Male or female subject ≥ 20 years of age at screening
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At least one kidney
-
Subjects who meet one of the 1 or 2 following criteria
- Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) 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) with the last screening Hb measurement within 14 days prior to study drug assignment
- Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and < 13.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment
-
Subjects who meet one of the 1 or 2 following criteria
-
Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol
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Subjects pre treated with ESA at assignment:
- Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment
- Subject treated with ESA by IV or SC within 8 weeks prior to assignment
- Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment
-
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Molidustat (BAY85-3934) Molidustat (BAY85-3934) Molidustat group
- Primary Outcome Measures
Name Time Method Responder rate: proportion of responders among the subjects 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 treatment
- Secondary Outcome Measures
Name Time Method Change in mean Hb level Baseline and Week 30 to 36 Proportion of subjects with mean hemoglobin levels are in the target range Week 30 to 36 Proportion of subjects with hemoglobin levels in the target range Up to 36 weeks Percentage of days in the target Hb range during the evaluation period Week 30 to 36 Mean Hb (Hemoglobin) level Week 30 to 36 Rate of rise in Hb (Hemoglobin) level (g/dL/week) Up to 4 weeks Change in Hb level Baseline and Up to Week 36 Proportion of subjects who meet each component of the response 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 with mean hemoglobin levels are below the target range Week 30 to 36 Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week Up to 36 weeks Defined as change in Hb level / duration between two visits (weeks)
Proportion of subjects whose Hb level was ≥ 13.0 g/dL or < 8.0 g/dL Up to 36 weeks Proportion of subjects with hemoglobin levels above the target range Up to 36 weeks Proportion of subjects with mean hemoglobin levels are above the target range Week 30 to 36 Percentage of Hb levels in target range during the evaluation period Week 30 to 36 Defined as the number of measurements in the target range / number of measurements x 100 \[%\])
Percentage of days in the target Hb range during the treatment period Up to 36 weeks Number of participants with serious adverse events Up to 36 weeks Percentage of Hb levels in target range during the treatment period Up to 36 weeks Defined as the number of measurements in the target range / number of measurements x 100 \[%\])
Proportion of subjects who received at least one rescue treatment Up to 36 weeks EPO (Erythropoietin) serum concentration of Molidustat Baseline, Week 8, Wee16 and Week 36 Rate of rise in Hb level (g/dL/week) between each consecutive visits Up to 36 weeks Maximum concentration (Cmax) of Molidustat Baseline, Week 8, Wee16 and Week 36 Area under the concentration-time curve (AUC) of Molidustat Baseline, Week 8, Wee16 and Week 36 Proportion of subjects with hemoglobin levels below the target range Up to 36 weeks Hb level Baseline and Up to Week 36
Trial Locations
- Locations (27)
Japanese Red Cross Fukuoka Hospital
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Asahi University Hospital
🇯🇵Gifu, Japan
JCHO Kyushu Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Elm Grove Clinic
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Beppu Medical Center
🇯🇵Beppu, Oita, Japan
Fuchu Hospital
🇯🇵Izumi, Osaka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Nara Prefecture General Medical Center
🇯🇵Nara, Japan
National Hospital Organization Kyoto Medical Center
🇯🇵Kyoto, Japan
Japanese Red Cross Oita Hospital
🇯🇵Oita, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Fukui-ken Saiseikai Hospital
🇯🇵Fukui, Japan
Showa University Fujigaoka Hospital
🇯🇵Yokohama, Kanagawa, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Toranomon Hospital Kajigaya
🇯🇵Kawasaki, Kanagawa, Japan
Tohoku Medical and Pharmaceutical University Hospital
🇯🇵Sendai, Miyagi, Japan
Kainan Hospital
🇯🇵Yatomi, Aichi, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
Okinawa prefectural Chubu Hospital
🇯🇵Uruma, Okinawa, Japan
Niigata City General Hospital
🇯🇵Niigata, Japan
Niigata Prefectural Shibata Hospital
🇯🇵Shibata, Niigata, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan