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

Phase 3

Completed

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

• Registration Number: NCT03350321
• Lead Sponsor: Bayer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-22
• Study Start: 2017-12-12
• Primary Completion: 2019-05-17
• Study Completion: 2019-10-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean Hb (Hemoglobin) level	From week 30 to 36
Change in hemoglobin level from baseline to the average during the evaluation period	Baseline and week 30 to 36

Secondary Outcome Measures

Name	Time	Method
Hb level	Baseline and up to 52 weeks
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once	Up to 52 weeks
Change in Hb level	Baseline and up to 52 weeks
Responder rate: proportion of responders among the subjects	From week 30 to 36	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 4 weeks
Proportion of subjects who meet each component of the response	From week 30 to 36	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
Proportion of subjects whose mean hemoglobin level is in the target range	From week 30 to 36
Proportion of subjects whose mean hemoglobin level is above the target range	From week 30 to 36
Proportion of subjects whose mean hemoglobin level is below the target range	From week 30 to 36
Proportion of subjects with hemoglobin levels in the target range	Up to 52 weeks
Proportion of subjects with hemoglobin levels above the target range	Up to 52 weeks
Proportion of subjects with hemoglobin levels below the target range	Up to 52 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week	Up to 52 weeks	Defined as change in Hb level / duration between two visits (weeks)
Number of participants with serious adverse events	Up to 52 weeks
Maximum concentration (Cmax)	At baseline, week 12, week 24 and week 52
Area under the concentration-time curve (AUC)	At baseline, week 12, week 24 and week 52
EPO (Erythropoietin) serum concentration	At baseline, week 12, week 24 and week 52

Trial Locations

Locations (61)

Kainan Hospital; 🇯🇵 Yatomi, Aichi, Japan

Seikeikai New Tokyo Heart Clinic; 🇯🇵 Matsudo, Chiba, Japan

Ehime Prefectural Central Hospital; 🇯🇵 Matsuyama, Ehime, Japan

Saiseikai Matsuyama Hospital; 🇯🇵 Matsuyama, Ehime, Japan

Iizuka Hospital; 🇯🇵 Iizuka, Fukuoka, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Steel Memorial Yawata Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

National Fukuoka-Higashi Medical Center; 🇯🇵 Koga, Fukuoka, Japan

Kurume University Hospital; 🇯🇵 Kurume, Fukuoka, Japan

St.Mary's Hospital; 🇯🇵 Kurume, Fukuoka, Japan

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