A Study of Molidustat for Maintenance Treatment 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: NCT03350347
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously 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: 2017-12-13
• Primary Completion: 2019-07-05
• Study Completion: 2019-11-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
• Have used the same ESA for 8 weeks prior to screening
• Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
• 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
• Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week 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%

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 (blood pressure)≥ 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
Change in hemoglobin level from baseline to the average during the evaluation period	Baseline and week 30 to 36
Mean Hb (Hemoglobin) level	From week 30 to 36

Secondary Outcome Measures

Name	Time	Method
Number of participants with serious adverse events	Up to 52 weeks
Proportion of subjects whose hemoglobin levels are below the target range	Up to 52 weeks
EPO (Erythropoietin) serum concentration of Molidustat	At baseline, week 12, week 24 and week 52
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period	From week 30 to 36
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
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
Hb level	Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period	From week 30 to 36
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period	From week 30 to 36
Proportion of subjects whose hemoglobin levels are in 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)
Change in Hb level	Baseline and up to 52 weeks
Maximum concentration (Cmax) of Molidustat	At baseline, week 12, week 24 and week 52
Proportion of subjects whose hemoglobin levels are above the target range	Up to 52 weeks
Area under the concentration-time curve (AUC) of Molidustat	At baseline, week 12, week 24 and week 52

Trial Locations

Locations (59)

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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