check_circleStudy Completed
Anemia, Renal Insufficiency, Chronic
Bayer Identifier:
19351
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study of Molidustat for correction of renal anemia in dialysis subjects
Trial purpose
The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)
Key Participants Requirements
Sex
AllAge
20 - N/ATrial summary
Enrollment Goal
25Trial Dates
January 2018 - November 2018Phase
Phase 3Could I Receive a placebo
NoProducts
Musredo (Molidustat, BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Itami Kidney Clinic | Noboribetsu, 059-0026, Japan |
Completed | Ishikari Hospital | Ishikari, 061-3213, Japan |
Completed | Japanese Red Cross Ishinomaki Hospital | Ishinomaki, 986-8522, Japan |
Completed | Tokiwa Clinic | Totte, 302-0011, Japan |
Completed | Kikuchi Medical Clinic | Tsukuba, 305-0861, Japan |
Completed | Asahikawa-Kosei General Hospital | Asahikawa, 078-8211, Japan |
Completed | Souen Central Hospital | Sapporo, 060-0008, Japan |
Withdrawn | Seisuikai Yoshioka Mahoroba Clinic | Kurokawa-gun, 981-3632, Japan |
Completed | Yamagata Tokushukai Hospital | Yamagata, 990-0834, Japan |
Completed | Tsuchiura Beryl Clinic | Tsuchiura, 300-0062, Japan |
Completed | Ohmiya Chuo General Hospital | Saitama, 331-8711, Japan |
Completed | Matsunami General Hospital | Hashima-gun, 501-6062, Japan |
Completed | Toyonaka Keijinkai Clinic | Toyonaka, 560-0004, Japan |
Completed | Takasago Seibu Hospital | Takasago, 676-0812, Japan |
Completed | Mito Kyodo General Hospital | Mito, 310-0015, Japan |
Completed | Japanese Red Cross Koga Hospital | Koga, 306-0014, Japan |
Completed | Houshikai Kano hospital | Kasuya-gun, 811-0120, Japan |
Completed | Fukuoka Renal Clinic | Fukuoka, 810-0004, Japan |
Completed | Medical corporation association Shunshin-kai Inage hospital | Chiba, 263-0043, Japan |
Completed | Iida Hospital | Iida, 395-8505, Japan |
Completed | Kodaira Kitaguchi Clinic | Kodaira, 187-0001, Japan |
Primary Outcome
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)date_rangeTime Frame:Up to 8 weeks
- 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 21 to 24
Secondary Outcome
- 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 21 to 24
- Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visitdate_rangeTime Frame:Up to 24 weeks
- Hb leveldate_rangeTime Frame:Baseline and up to 24 weeks
- Change in Hb leveldate_rangeTime Frame:Baseline and up to 24 weeks
- Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation perioddate_rangeTime Frame:Week 21 to 24
- Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation perioddate_rangeTime Frame:Week 21 to 24
- Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation perioddate_rangeTime Frame:Week 21 to 24
- Proportion of subjects with hemoglobin levels above the target rangedate_rangeTime Frame:Up to 24 weeks
- Proportion of subjects with hemoglobin levels below the target rangedate_rangeTime Frame:Up to 24 weeks
- Proportion of subjects with hemoglobin levels in the target rangedate_rangeTime Frame:Up to 24 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 24 weeks
- Number of participants with serious adverse eventsdate_rangeTime Frame:Up to 24 weeks
- Maximum concentration (Cmax) of Molidustatdate_rangeTime Frame:Baseline, Week 8, Week16 and Week 24
- Area under the concentration-time curve (AUC) of Molidustatdate_rangeTime Frame:Baseline, Week 8, Week16 and Week 24
- EPO (Erythropoietin) serum concentration of Molidustatdate_rangeTime Frame:Baseline, Week 8, Week16 and Week 24
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1