A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects

Anemia Clinical Trial

— MIYABI ND-C  

Official title:

A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350321
• Other study ID #: 19349
• Status: Completed
• Phase: Phase 3
• Start date: December 12, 2017
• Est. completion date: October 11, 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 non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 11, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)

• Body weight > 40 and = 160 kg at screening

• Male or female subject = 20 years of age at screening

• Not on dialysis and not expected to start dialysis during the study period

• Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization

• Mean of the last 2 central laboratory Hb levels 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) and the last measurements must be taken within 14 days prior to randomization

• Ferritin = 50 ng/mL at screening

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
• Darbepoetin alfa
Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response

Locations

Country	Name	City	State
Japan	Mazda Hospital of Mazda Motor Corporation	Aki-gun	Hiroshima
Japan	Arao Municipal Hospital	Arao	Kumamoto
Japan	University of Yamanashi Hospital	Chuo	Yamanashi
Japan	Fujisawa City Hospital	Fujisawa	Kanagawa
Japan	Fukui Prefectural Hospital	Fukui
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Nippon Kokan Fukuyama Hospital	Fukuyama	Hiroshima
Japan	Asahi University Hospital	Gifu
Japan	Matsunami Health Promotion Clinic	Hashima-gun	Gifu
Japan	National hospital Organization Mito Medical Center	Higashiibaraki	Ibaraki
Japan	Iizuka Hospital	Iizuka	Fukuoka
Japan	Japanese Red Cross Ishinomaki Hospital	Ishinomaki	Miyagi
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Toshima Hospital	Itabashi-ku	Tokyo
Japan	Iwata City Hospital	Iwata	Shizuoka
Japan	Ikeda Hospital	Kanoya	Kagoshima
Japan	Koukan Clinic	Kawasaki	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Steel Memorial Yawata Hospital	Kitakyushu	Fukuoka
Japan	Kitasato University Medical Center	Kitamoto	Saitama
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	National Hospital Organization Kobe Medical Center	Kobe	Hyogo
Japan	National Hospital Organization Kochi National Hospital	Kochi
Japan	National Fukuoka-Higashi Medical Center	Koga	Fukuoka
Japan	Asama Nanroku Komoro Medical Center	Komoro	Nagano
Japan	Showa University Koto Toyosu Hospital	Koto-ku	Tokyo
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	St.Mary's Hospital	Kurume	Fukuoka
Japan	Seikeikai New Tokyo Heart Clinic	Matsudo	Chiba
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	Saiseikai Matsuyama Hospital	Matsuyama	Ehime
Japan	National Hospital Organization Tokyo Medical Center	Meguro-ku	Tokyo
Japan	Mito Kyodo General Hospital	Mito	Ibaraki
Japan	Nara Prefecture General Medical Center	Nara
Japan	Japanese Red Cross Oita Hospital	Oita
Japan	Chibune Clinic	Osaka
Japan	Kitano Hospital	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Nippon Life Hospital	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Red Cross Hospital	Osaka
Japan	Social Corporation Keigakukai Minamiosaka Hospital	Osaka
Japan	Teine Keijinkai Clinic	Sapporo	Hokkaido
Japan	Niigata Prefectural Shibata Hospital	Shibata	Niigata
Japan	Shizuoka Saiseikai General Hospital	Shizuoka
Japan	Suruga Clinic	Shizuoka
Japan	Osaka Saiseikai Senri Hospital	Suita	Osaka
Japan	Gifu Prefectural Tajimi Hospital	Tajimi	Gifu
Japan	KenAiKai medical corporation Akiyama clinic	Takamatsu	Kagawa
Japan	Osaka Pref. Saiseikai Tondabayashi Hospital	Tondabayashi	Osaka
Japan	Uji-Tokushukai Medical Center	Uji	Kyoto
Japan	Okinawa prefectural Chubu Hospital	Uruma	Okinawa
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Kainan Hospital	Yatomi	Aichi
Japan	Kumamoto Rosai Hospital	Yatsushiro	Kumamoto
Japan	JCHO Yokkaichi Hazu Medical Center	Yokkaichi	Mie
Japan	Showa University Fujigaoka Hospital	Yokohama	Kanagawa
Japan	Yokosuka Kyosai Hospital	Yokosuka	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Hb (Hemoglobin) level		From week 30 to 36
Primary	Change in hemoglobin level from baseline to the average during the evaluation period		Baseline and week 30 to 36
Secondary	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	From 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	From week 30 to 36
Secondary	Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once		Up to 52 weeks
Secondary	Change in Hb level		Baseline and up to 52 weeks
Secondary	Hb level		Baseline and up to 52 weeks
Secondary	Proportion of subjects whose mean hemoglobin level is in the target range		From week 30 to 36
Secondary	Proportion of subjects whose mean hemoglobin level is above the target range		From week 30 to 36
Secondary	Proportion of subjects whose mean hemoglobin level is below the target range		From week 30 to 36
Secondary	Proportion of subjects with hemoglobin levels in the target range		Up to 52 weeks
Secondary	Proportion of subjects with hemoglobin levels above the target range		Up to 52 weeks
Secondary	Proportion of subjects with hemoglobin levels below the target range		Up to 52 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 52 weeks
Secondary	Number of participants with serious adverse events		Up to 52 weeks
Secondary	Maximum concentration (Cmax)		At baseline, week 12, week 24 and week 52
Secondary	Area under the concentration-time curve (AUC)		At baseline, week 12, week 24 and week 52
Secondary	EPO (Erythropoietin) serum concentration		At baseline, week 12, week 24 and week 52

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