check_circleStudy Completed
Anemia, Renal Insufficiency, Chronic
Bayer Identifier:
19353
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study of Molidustat for treatment of renal anemia in peritoneal dialysis subjects
Trial purpose
The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia
Key Participants Requirements
Sex
AllAge
20 - N/ATrial summary
Enrollment Goal
51Trial Dates
February 2018 - July 2019Phase
Phase 3Could I Receive a placebo
NoProducts
Musredo (Molidustat, BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Fukushima Medical University Hospital | Fukushima, 960-1295, Japan |
Completed | Niigata Prefectural Shibata Hospital | Shibata, 957-8588, Japan |
Completed | Showa University Fujigaoka Hospital | Yokohama, 227-8501, Japan |
Completed | Fujisawa City Hospital | Fujisawa, 251-8550, Japan |
Completed | Shonan Kamakura General Hospital | Kamakura, 247-8533, Japan |
Completed | Kainan Hospital | Yatomi, 498-8502, Japan |
Completed | Asahi University Hospital | Gifu, 500-8523, Japan |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Nara Prefecture General Medical Center | Nara, 630-8581, Japan |
Completed | Ehime Prefectural Central Hospital | Matsuyama, 790-0024, Japan |
Completed | Kokura Memorial Hospital | Kitakyushu, 802-8555, Japan |
Completed | Kyushu University Hospital | Fukuoka, 812-8582, Japan |
Completed | Fukuoka University Hospital | Fukuoka, 814-0180, Japan |
Completed | JCHO Kyushu Hospital | Kitakyushu, 806-8501, Japan |
Completed | Japanese Red Cross Fukuoka Hospital | Fukuoka, 815-8555, Japan |
Completed | Kurume University Hospital | Kurume, 830-0011, Japan |
Completed | Japanese Red Cross Oita Hospital | Oita, 870-0033, Japan |
Completed | Okinawa prefectural Chubu Hospital | Uruma, 904-2293, Japan |
Completed | Elm Grove Clinic | Sapporo, 003-0814, Japan |
Completed | Tohoku Medical and Pharmaceutical University Hospital | Sendai, 983-8512, Japan |
Completed | Niigata City General Hospital | Niigata, 950-1197, Japan |
Completed | Toranomon Hospital Kajigaya | Kawasaki, 213-8587, Japan |
Completed | Fukui-ken Saiseikai Hospital | Fukui, 918-8503, Japan |
Completed | National Hospital Organization Kyoto Medical Center | Kyoto, 612-8555, Japan |
Completed | Fuchu Hospital | Izumi, 594-0076, Japan |
Completed | Kobe City Medical Center General Hospital | Kobe, 650-0047, Japan |
Completed | National Hospital Organization Beppu Medical Center | Beppu, 874-0011, Japan |
Primary Outcome
- Responder rate: proportion of responders among the subjectsResponder 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 treatmentdate_rangeTime Frame:Week 30 to 36
Secondary Outcome
- Mean Hb (Hemoglobin) leveldate_rangeTime Frame:Week 30 to 36
- Change in mean Hb leveldate_rangeTime Frame:Baseline and Week 30 to 36
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)date_rangeTime Frame:Up to 8 weeks
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)date_rangeTime Frame:Up to 4 weeks
- Proportion of subjects who meet each component of the responseResponse: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatmentdate_rangeTime Frame:Week 30 to 36
- Hb leveldate_rangeTime Frame:Baseline and Up to Week 36
- Change in Hb leveldate_rangeTime Frame:Baseline and Up to Week 36
- Proportion of subjects with mean hemoglobin levels are in the target rangedate_rangeTime Frame:Week 30 to 36
- Proportion of subjects with mean hemoglobin levels are above the target rangedate_rangeTime Frame:Week 30 to 36
- Proportion of subjects with mean hemoglobin levels are below the target rangedate_rangeTime Frame:Week 30 to 36
- Proportion of subjects with hemoglobin levels in the target rangedate_rangeTime Frame:Up to 36 weeks
- Proportion of subjects with hemoglobin levels above the target rangedate_rangeTime Frame:Up to 36 weeks
- Proportion of subjects with hemoglobin levels below the target rangedate_rangeTime Frame:Up to 36 weeks
- Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/weekDefined as change in Hb level / duration between two visits (weeks)date_rangeTime Frame:Up to 36 weeks
- Percentage of days in the target Hb range during the evaluation perioddate_rangeTime Frame:Week 30 to 36
- Percentage of days in the target Hb range during the treatment perioddate_rangeTime Frame:Up to 36 weeks
- Rate of rise in Hb level (g/dL/week) between each consecutive visitsdate_rangeTime Frame:Up to 36 weeks
- Percentage of Hb levels in target range during the evaluation periodDefined as the number of measurements in the target range / number of measurements x 100 [%])date_rangeTime Frame:Week 30 to 36
- Percentage of Hb levels in target range during the treatment periodDefined as the number of measurements in the target range / number of measurements x 100 [%])date_rangeTime Frame:Up to 36 weeks
- Proportion of subjects who received at least one rescue treatmentdate_rangeTime Frame:Up to 36 weeks
- Proportion of subjects whose Hb level was ≥ 13.0 g/dL or < 8.0 g/dLdate_rangeTime Frame:Up to 36 weeks
- Number of participants with serious adverse eventsdate_rangeTime Frame:Up to 36 weeks
- Maximum concentration (Cmax) of Molidustatdate_rangeTime Frame:Baseline, Week 8, Wee16 and Week 36
- Area under the concentration-time curve (AUC) of Molidustatdate_rangeTime Frame:Baseline, Week 8, Wee16 and Week 36
- EPO (Erythropoietin) serum concentration of Molidustatdate_rangeTime Frame:Baseline, Week 8, Wee16 and Week 36
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1