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

Phase 3

Completed

• Conditions: Renal Insufficiency, Chronic; Anemia
• Interventions: Drug: Molidustat (BAY85-3934)

• Registration Number: NCT03351166
• Lead Sponsor: Bayer

Brief 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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2018-01-22
• Primary Completion: 2018-10-23
• Study Completion: 2018-11-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Molidustat (BAY85-3934)	Molidustat (BAY85-3934)	Molidustat group

Primary Outcome Measures

Name	Time	Method
Responder rate: proportion of responders among the subjects	Week 21 to 24	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
Rate of rise in Hb (Hemoglobin) level (g/dL/week)	Up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Hb level	Baseline and up to 24 weeks
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period	Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period	Week 21 to 24
Proportion of subjects with hemoglobin levels above the target range	Up to 24 weeks
Proportion of subjects with hemoglobin levels below the target range	Up to 24 weeks
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period	Week 21 to 24
Area under the concentration-time curve (AUC) of Molidustat	Baseline, Week 8, Week16 and Week 24
Change in Hb level	Baseline and up to 24 weeks
Proportion of subjects who meet each component of the response	Week 21 to 24	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
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit	Up to 24 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week	Up to 24 weeks	Defined as change in Hb level / duration between two visits (weeks)
Number of participants with serious adverse events	Up to 24 weeks
Maximum concentration (Cmax) of Molidustat	Baseline, Week 8, Week16 and Week 24
Rate of rise in Hb (Hemoglobin) level (g/dL/week)	Up to 4 weeks
Proportion of subjects with hemoglobin levels in the target range	Up to 24 weeks
EPO (Erythropoietin) serum concentration of Molidustat	Baseline, Week 8, Week16 and Week 24

Trial Locations

Locations (20)

Houshikai Kano hospital; 🇯🇵 Kasuya-gun, Fukuoka, Japan

Asahikawa-Kosei General Hospital; 🇯🇵 Asahikawa, Hokkaido, Japan

Ishikari Hospital; 🇯🇵 Ishikari, Hokkaido, Japan

Itami Kidney Clinic; 🇯🇵 Noboribetsu, Hokkaido, Japan

Souen Central Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Mito Kyodo General Hospital; 🇯🇵 Mito, Ibaraki, Japan

Tsuchiura Beryl Clinic; 🇯🇵 Tsuchiura, Ibaraki, Japan

Kikuchi Medical Clinic; 🇯🇵 Tsukuba, Ibaraki, Japan

Japanese Red Cross Ishinomaki Hospital; 🇯🇵 Ishinomaki, Miyagi, Japan

Iida Hospital; 🇯🇵 Iida, Nagano, Japan

Toyonaka Keijinkai Clinic; 🇯🇵 Toyonaka, Osaka, Japan

Kodaira Kitaguchi Clinic; 🇯🇵 Kodaira, Tokyo, Japan

Fukuoka Renal Clinic; 🇯🇵 Fukuoka, Japan

Ohmiya Chuo General Hospital; 🇯🇵 Saitama, Japan

Yamagata Tokushukai Hospital; 🇯🇵 Yamagata, Japan

Takasago Seibu Hospital; 🇯🇵 Takasago, Hyogo, Japan

Matsunami General Hospital; 🇯🇵 Hashima-gun, Gifu, Japan

Medical corporation association Shunshin-kai Inage hospital; 🇯🇵 Chiba, Japan

Japanese Red Cross Koga Hospital; 🇯🇵 Koga, Ibaraki, Japan

Tokiwa Clinic; 🇯🇵 Totte, Ibaraki, Japan