Maintenance Treatment of Renal Anemia in Dialysis Subjects

Anemia Clinical Trial

— MIYABI HD-M  

Official title:

A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543657
• Other study ID #: 19352
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2018
• Est. completion date: December 24, 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 comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: December 24, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization

• Body weight (after dialysis) > 40 and = 160 kg at screening

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

• At least one kidney

• Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization

• Mean screening Hb level = 9.5 and < 12.0 g/dL (mean of all central laboratory Hb levels before dialysis [at least 2 measurements must be taken = 2 days apart] during the screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is < 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization

• Ferritin = 100 ng/mL or transferrin saturation = 20% at screening

• Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) 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, poorly controlled arterial hypertension (defined as systolic BP (blood pressure) = 180mmHg or diastolic BP = 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization

• Proliferative choroidal or retinal disease, such as neovascular agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening

Related Conditions & MeSH terms

• Anemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Molidustat (BAY85-3934)
Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).
• Darbepoetin alfa
Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.
• Placebo of Molidustat (BAY85-3934)
Matching placebo of Molidustat.
• Placebo of Darbepoetin alfa
Matching placebo of Darbepoetin alfa.

Locations

Country	Name	City	State
Japan	Asahikawa-Kosei General Hospital	Asahikawa	Hokkaido
Japan	Honatsugi Medical Clinic	Atsugi	Kanagawa
Japan	Medical corporation association Shunshin-kai Inage hospital	Chiba
Japan	Chigasaki Central Clinic	Chigasaki	Kanagawa
Japan	Koizumi Cardiology Medical Clinic	Chitose	Hokkaido
Japan	Ikeda Vascular Access Nephrology Dialysis	Fukuoka
Japan	Oohashi internal medicine circulatory Clinic	Fukuoka
Japan	Hachioji Azumacho Clinic	Hachioji	Tokyo
Japan	Public Central Hospital of Matto Ishikawa	Hakusan	Ishikawa
Japan	Hanyu General Hospital	Hanyu	Saitama
Japan	Higashimatsuyamakohjin Clinic	Higashimatsuyama	Saitama
Japan	Arisawa General Hospital	Hirakata	Osaka
Japan	Iida Hospital	Iida	Nagano
Japan	Ishikari Hospital	Ishikari	Hokkaido
Japan	Ibaraki Prefectural Central Hospital	Kasama	Ibaraki
Japan	Shinkashiwa Clinic	Kashiwa	Chiba
Japan	Houshikai Kano hospital	Kasuya-gun	Fukuoka
Japan	Kisarazu Clinic	Kisarazu	Chiba
Japan	Saiseikai Yahata General Hospital	Kitakyushu	Fukuoka
Japan	Kodaira Kitaguchi Clinic	Kodaira	Tokyo
Japan	Japanese Red Cross Koga Hospital	Koga	Ibaraki
Japan	Saiyu Clinic	Koshigaya	Saitama
Japan	Ueki Imafuji Clinic	Kumamoto
Japan	Seisuikai Yoshioka Mahoroba Clinic	Kurokawa-gun	Miyagi
Japan	Kanno Dialysis & Vascular Access Clinic	Matsumoto	Nagano
Japan	Matsumoto City Hospital	Matsumoto	Nagano
Japan	Sanshikai Toho Hospital	Midori	Gunma
Japan	Mito Kyodo General Hospital	Mito	Ibaraki
Japan	Medical Corporation Suzukihinyoukika	Nagano
Japan	Nagasaki Kidney Hospital	Nagasaki
Japan	Hakuyoukai Medical corporation Hakuyoukai Hospital	Nagoya	Aichi
Japan	Kuwajima Clinic	Niihama	Ehime
Japan	Itami Kidney Clinic	Noboribetsu	Hokkaido
Japan	Akagaki Clinic	Osaka
Japan	Chibune Clinic	Osaka
Japan	Nishi Shinryosho	Osaka
Japan	Eijinkai Hospital	Osaki	Miyagi
Japan	Sabae kidney Clinic	Sabae	Fukui
Japan	Toshiba Rinkan Hospital	Sagamihara	Kanagawa
Japan	Iwatsuki-minami Hospital	Saitama
Japan	Kaisei Hospital	Sakaide	Kagawa
Japan	Souen Central Hospital	Sapporo	Hokkaido
Japan	Todachuo General Hospital	Toda	Saitama
Japan	Tokiwa Clinic	Totte	Ibaraki
Japan	Toyonaka Keijinkai Clinic	Toyonaka	Osaka
Japan	Tsuchiura Beryl Clinic	Tsuchiura	Ibaraki
Japan	Kikuchi Medical Clinic	Tsukuba	Ibaraki
Japan	Saint Hill Hospital	Ube	Yamaguchi
Japan	Maruko Central Hospital	Ueda	Nagano
Japan	Yamagata Tokushukai Hospital	Yamagata
Japan	Eda Clinic	Yokohama	Kanagawa
Japan	Kaminagaya Saitou Clinic	Yokohama	Kanagawa
Japan	Yokohama Jin Clinic	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean Hb level during the evaluation period		From week 33 to 36
Primary	The change in mean Hb level during the evaluation period from baseline		Baseline and week 33 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 33 to 36
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 33 to 36
Secondary	Hb level		Up to 52 weeks
Secondary	Change in Hb level		Baseline and up to 52 weeks
Secondary	Proportion of subjects whose mean hemoglobin level is in the target range		From week 33 to 36
Secondary	Proportion of subjects whose mean hemoglobin level is above the target range		From week 33 to 36
Secondary	Proportion of subjects whose mean hemoglobin level is below the target range		From week 33 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 8, week 24 and week 52
Secondary	Area under the concentration-time curve (AUC)		At baseline, week 8, week 24 and week 52
Secondary	EPO (Erythropoietin) serum concentration		At baseline, week 8, week 24 and week 52

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