A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects

Anemia Clinical Trial

— MIYABI PD  

Official title:

An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418168
• Other study ID #: 19353
• Status: Completed
• Phase: Phase 3
• Start date: February 22, 2018
• Est. completion date: July 29, 2019

Study information

• Verified date: January 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 29, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Anemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Molidustat (BAY85-3934)
Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response

Locations

Country	Name	City	State
Japan	National Hospital Organization Beppu Medical Center	Beppu	Oita
Japan	Fujisawa City Hospital	Fujisawa	Kanagawa
Japan	Fukui-ken Saiseikai Hospital	Fukui
Japan	Fukuoka University Hospital	Fukuoka
Japan	Japanese Red Cross Fukuoka Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Asahi University Hospital	Gifu
Japan	Fuchu Hospital	Izumi	Osaka
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Toranomon Hospital Kajigaya	Kawasaki	Kanagawa
Japan	JCHO Kyushu Hospital	Kitakyushu	Fukuoka
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	Nara Prefecture General Medical Center	Nara
Japan	Niigata City General Hospital	Niigata
Japan	Japanese Red Cross Oita Hospital	Oita
Japan	Osaka General Medical Center	Osaka
Japan	Elm Grove Clinic	Sapporo	Hokkaido
Japan	Tohoku Medical and Pharmaceutical University Hospital	Sendai	Miyagi
Japan	Niigata Prefectural Shibata Hospital	Shibata	Niigata
Japan	Okinawa prefectural Chubu Hospital	Uruma	Okinawa
Japan	Kainan Hospital	Yatomi	Aichi
Japan	Showa University Fujigaoka Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 30 to 36
Secondary	Mean Hb (Hemoglobin) level		Week 30 to 36
Secondary	Change in mean Hb level		Baseline and Week 30 to 36
Secondary	Rate of rise in Hb (Hemoglobin) level (g/dL/week)		Up to 8 weeks
Secondary	Rate of rise in Hb (Hemoglobin) level (g/dL/week)		Up to 4 weeks
Secondary	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	Week 30 to 36
Secondary	Hb level		Baseline and Up to Week 36
Secondary	Change in Hb level		Baseline and Up to Week 36
Secondary	Proportion of subjects with mean hemoglobin levels are in the target range		Week 30 to 36
Secondary	Proportion of subjects with mean hemoglobin levels are above the target range		Week 30 to 36
Secondary	Proportion of subjects with mean hemoglobin levels are below the target range		Week 30 to 36
Secondary	Proportion of subjects with hemoglobin levels in the target range		Up to 36 weeks
Secondary	Proportion of subjects with hemoglobin levels above the target range		Up to 36 weeks
Secondary	Proportion of subjects with hemoglobin levels below the target range		Up to 36 weeks
Secondary	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)	Up to 36 weeks
Secondary	Percentage of days in the target Hb range during the evaluation period		Week 30 to 36
Secondary	Percentage of days in the target Hb range during the treatment period		Up to 36 weeks
Secondary	Rate of rise in Hb level (g/dL/week) between each consecutive visits		Up to 36 weeks
Secondary	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 [%])	Week 30 to 36
Secondary	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 [%])	Up to 36 weeks
Secondary	Proportion of subjects who received at least one rescue treatment		Up to 36 weeks
Secondary	Proportion of subjects whose Hb level was = 13.0 g/dL or < 8.0 g/dL		Up to 36 weeks
Secondary	Number of participants with serious adverse events		Up to 36 weeks
Secondary	Maximum concentration (Cmax) of Molidustat		Baseline, Week 8, Wee16 and Week 36
Secondary	Area under the concentration-time curve (AUC) of Molidustat		Baseline, Week 8, Wee16 and Week 36
Secondary	EPO (Erythropoietin) serum concentration of Molidustat		Baseline, Week 8, Wee16 and Week 36

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