check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

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

All

Age

20 - N/A
  • - Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly
    - Body weight > 40 and ≤ 160 kg at screening
    - Male or female subject ≥ 20 years of age at screening
    - At least one kidney
    - Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol
    - Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 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
    - 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)

Trial summary

Enrollment Goal
25
Trial Dates
January 2018 - November 2018
Phase
Phase 3
Could I Receive a placebo
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Itami Kidney ClinicNoboribetsu, 059-0026, Japan
Completed
Ishikari HospitalIshikari, 061-3213, Japan
Completed
Japanese Red Cross Ishinomaki HospitalIshinomaki, 986-8522, Japan
Completed
Tokiwa ClinicTotte, 302-0011, Japan
Completed
Kikuchi Medical ClinicTsukuba, 305-0861, Japan
Completed
Asahikawa-Kosei General HospitalAsahikawa, 078-8211, Japan
Completed
Souen Central HospitalSapporo, 060-0008, Japan
Withdrawn
Seisuikai Yoshioka Mahoroba ClinicKurokawa-gun, 981-3632, Japan
Completed
Yamagata Tokushukai HospitalYamagata, 990-0834, Japan
Completed
Tsuchiura Beryl ClinicTsuchiura, 300-0062, Japan
Completed
Ohmiya Chuo General HospitalSaitama, 331-8711, Japan
Completed
Matsunami General HospitalHashima-gun, 501-6062, Japan
Completed
Toyonaka Keijinkai ClinicToyonaka, 560-0004, Japan
Completed
Takasago Seibu HospitalTakasago, 676-0812, Japan
Completed
Mito Kyodo General HospitalMito, 310-0015, Japan
Completed
Japanese Red Cross Koga HospitalKoga, 306-0014, Japan
Completed
Houshikai Kano hospitalKasuya-gun, 811-0120, Japan
Completed
Fukuoka Renal ClinicFukuoka, 810-0004, Japan
Completed
Medical corporation association Shunshin-kai Inage hospitalChiba, 263-0043, Japan
Completed
Iida HospitalIida, 395-8505, Japan
Completed
Kodaira Kitaguchi ClinicKodaira, 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 subjects
    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
    date_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 response
    Response: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
    date_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 visit
    date_rangeTime Frame:
    Up to 24 weeks
  • Hb level
    date_rangeTime Frame:
    Baseline and up to 24 weeks
  • Change in Hb level
    date_rangeTime Frame:
    Baseline and up to 24 weeks
  • Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
    date_rangeTime Frame:
    Week 21 to 24
  • Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
    date_rangeTime Frame:
    Week 21 to 24
  • Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
    date_rangeTime Frame:
    Week 21 to 24
  • Proportion of subjects with hemoglobin levels above the target range
    date_rangeTime Frame:
    Up to 24 weeks
  • Proportion of subjects with hemoglobin levels below the target range
    date_rangeTime Frame:
    Up to 24 weeks
  • Proportion of subjects with hemoglobin levels in the target range
    date_rangeTime Frame:
    Up to 24 weeks
  • Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
    Defined as change in Hb level / duration between two visits (weeks)
    date_rangeTime Frame:
    Up to 24 weeks
  • Number of participants with serious adverse events
    date_rangeTime Frame:
    Up to 24 weeks
  • Maximum concentration (Cmax) of Molidustat
    date_rangeTime Frame:
    Baseline, Week 8, Week16 and Week 24
  • Area under the concentration-time curve (AUC) of Molidustat
    date_rangeTime Frame:
    Baseline, Week 8, Week16 and Week 24
  • EPO (Erythropoietin) serum concentration of Molidustat
    date_rangeTime Frame:
    Baseline, Week 8, Week16 and Week 24

Trial design

A single arm, multicenter study to investigate the efficacy and safety of oral molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1