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A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)

NCT03350347•Bayer

View on ClinicalTrials.gov

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)

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (59)

Kainan Hospital

Yatomi, Aichi-ken, 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

Key Dates

Start Date

December 13, 2017

Primary Completion Date

July 5, 2019

Completion Date

November 28, 2019

Last Updated

January 29, 2021

Enrollment

164

ACTUAL participants

Conditions

AnemiaRenal Insufficiency, Chronic

Interventions

Molidustat (BAY85-3934)

DRUG

Darbepoetin alfa

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

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