check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

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

All

Age

20 - N/A
  • - 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
    - 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
     -- 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)

Trial summary

Enrollment Goal
51
Trial Dates
February 2018 - July 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Completed
Niigata Prefectural Shibata HospitalShibata, 957-8588, Japan
Completed
Showa University Fujigaoka HospitalYokohama, 227-8501, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Completed
Kainan HospitalYatomi, 498-8502, Japan
Completed
Asahi University HospitalGifu, 500-8523, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Nara Prefecture General Medical CenterNara, 630-8581, Japan
Completed
Ehime Prefectural Central HospitalMatsuyama, 790-0024, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Fukuoka University HospitalFukuoka, 814-0180, Japan
Completed
JCHO Kyushu HospitalKitakyushu, 806-8501, Japan
Completed
Japanese Red Cross Fukuoka HospitalFukuoka, 815-8555, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
Japanese Red Cross Oita HospitalOita, 870-0033, Japan
Completed
Okinawa prefectural Chubu HospitalUruma, 904-2293, Japan
Completed
Elm Grove ClinicSapporo, 003-0814, Japan
Completed
Tohoku Medical and Pharmaceutical University HospitalSendai, 983-8512, Japan
Completed
Niigata City General HospitalNiigata, 950-1197, Japan
Completed
Toranomon Hospital KajigayaKawasaki, 213-8587, Japan
Completed
Fukui-ken Saiseikai HospitalFukui, 918-8503, Japan
Completed
National Hospital Organization Kyoto Medical CenterKyoto, 612-8555, Japan
Completed
Fuchu HospitalIzumi, 594-0076, Japan
Completed
Kobe City Medical Center General HospitalKobe, 650-0047, Japan
Completed
National Hospital Organization Beppu Medical CenterBeppu, 874-0011, Japan

Primary Outcome

  • 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 30 to 36

Secondary Outcome

  • Mean Hb (Hemoglobin) level
    date_rangeTime Frame:
    Week 30 to 36
  • Change in mean Hb level
    date_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 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 30 to 36
  • Hb level
    date_rangeTime Frame:
    Baseline and Up to Week 36
  • Change in Hb level
    date_rangeTime Frame:
    Baseline and Up to Week 36
  • Proportion of subjects with mean hemoglobin levels are in the target range
    date_rangeTime Frame:
    Week 30 to 36
  • Proportion of subjects with mean hemoglobin levels are above the target range
    date_rangeTime Frame:
    Week 30 to 36
  • Proportion of subjects with mean hemoglobin levels are below the target range
    date_rangeTime Frame:
    Week 30 to 36
  • Proportion of subjects with hemoglobin levels in the target range
    date_rangeTime Frame:
    Up to 36 weeks
  • Proportion of subjects with hemoglobin levels above the target range
    date_rangeTime Frame:
    Up to 36 weeks
  • Proportion of subjects with hemoglobin levels below the target range
    date_rangeTime Frame:
    Up to 36 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 36 weeks
  • Percentage of days in the target Hb range during the evaluation period
    date_rangeTime Frame:
    Week 30 to 36
  • Percentage of days in the target Hb range during the treatment period
    date_rangeTime Frame:
    Up to 36 weeks
  • Rate of rise in Hb level (g/dL/week) between each consecutive visits
    date_rangeTime Frame:
    Up to 36 weeks
  • Percentage of Hb levels in target range during the evaluation period
    Defined 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 period
    Defined 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 treatment
    date_rangeTime Frame:
    Up to 36 weeks
  • Proportion of subjects whose Hb level was ≥ 13.0 g/dL or < 8.0 g/dL
    date_rangeTime Frame:
    Up to 36 weeks
  • Number of participants with serious adverse events
    date_rangeTime Frame:
    Up to 36 weeks
  • Maximum concentration (Cmax) of Molidustat
    date_rangeTime Frame:
    Baseline, Week 8, Wee16 and Week 36
  • Area under the concentration-time curve (AUC) of Molidustat
    date_rangeTime Frame:
    Baseline, Week 8, Wee16 and Week 36
  • EPO (Erythropoietin) serum concentration of Molidustat
    date_rangeTime Frame:
    Baseline, Week 8, Wee16 and Week 36

Trial design

An open-label, multicenter study to investigate the efficacy and safety of oral molidustat in peritoneal dialysis subjects with renal anemia
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1