A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects

Anemia Clinical Trial

— MIYABI HD-C  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351166
• Other study ID #: 19351
• Status: Completed
• Phase: Phase 3
• Start date: January 22, 2018
• Est. completion date: November 20, 2018

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 dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 20, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

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	Asahikawa-Kosei General Hospital	Asahikawa	Hokkaido
Japan	Medical corporation association Shunshin-kai Inage hospital	Chiba
Japan	Fukuoka Renal Clinic	Fukuoka
Japan	Matsunami General Hospital	Hashima-gun	Gifu
Japan	Iida Hospital	Iida	Nagano
Japan	Ishikari Hospital	Ishikari	Hokkaido
Japan	Japanese Red Cross Ishinomaki Hospital	Ishinomaki	Miyagi
Japan	Houshikai Kano hospital	Kasuya-gun	Fukuoka
Japan	Kodaira Kitaguchi Clinic	Kodaira	Tokyo
Japan	Japanese Red Cross Koga Hospital	Koga	Ibaraki
Japan	Mito Kyodo General Hospital	Mito	Ibaraki
Japan	Itami Kidney Clinic	Noboribetsu	Hokkaido
Japan	Ohmiya Chuo General Hospital	Saitama
Japan	Souen Central Hospital	Sapporo	Hokkaido
Japan	Takasago Seibu Hospital	Takasago	Hyogo
Japan	Tokiwa Clinic	Totte	Ibaraki
Japan	Toyonaka Keijinkai Clinic	Toyonaka	Osaka
Japan	Tsuchiura Beryl Clinic	Tsuchiura	Ibaraki
Japan	Kikuchi Medical Clinic	Tsukuba	Ibaraki
Japan	Yamagata Tokushukai Hospital	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of rise in Hb (Hemoglobin) level (g/dL/week)		Up to 8 weeks
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 21 to 24
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 21 to 24
Secondary	Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit		Up to 24 weeks
Secondary	Hb level		Baseline and up to 24 weeks
Secondary	Change in Hb level		Baseline and up to 24 weeks
Secondary	Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period		Week 21 to 24
Secondary	Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period		Week 21 to 24
Secondary	Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period		Week 21 to 24
Secondary	Proportion of subjects with hemoglobin levels above the target range		Up to 24 weeks
Secondary	Proportion of subjects with hemoglobin levels below the target range		Up to 24 weeks
Secondary	Proportion of subjects with hemoglobin levels in the target range		Up to 24 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 24 weeks
Secondary	Number of participants with serious adverse events		Up to 24 weeks
Secondary	Maximum concentration (Cmax) of Molidustat		Baseline, Week 8, Week16 and Week 24
Secondary	Area under the concentration-time curve (AUC) of Molidustat		Baseline, Week 8, Week16 and Week 24
Secondary	EPO (Erythropoietin) serum concentration of Molidustat		Baseline, Week 8, Week16 and Week 24

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