A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects (MIYABI ND-C)

Bayer

Status and phase

Completed

Phase 3

Conditions

Anemia

Renal Insufficiency, Chronic

Treatments

Drug: Molidustat (BAY85-3934)

Drug: Darbepoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT03350321

19349

Details and patient eligibility

About

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).

Enrollment

162 patients

Sex

All

Ages

20+ years old

Volunteers

No 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)
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)