Maintenance Treatment of Renal Anemia in Dialysis Subjects (MIYABI HD-M)

Bayer

Status and phase: Completed; Phase 3

Conditions: Anemia; Renal Insufficiency, Chronic

Treatments: Drug: Molidustat (BAY85-3934); Drug: Darbepoetin alfa; Drug: Placebo of Darbepoetin alfa; Drug: Placebo of Molidustat (BAY85-3934)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03543657

19352

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

Enrollment: 229 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
• Body weight (after dialysis) > 40 and ≤ 160 kg at screening
• Male or female subject ≥ 20 years of age at screening
• At least one kidney
• Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
• Mean screening Hb level ≥ 9.5 and < 12.0 g/dL (mean of all central laboratory Hb levels before dialysis [at least 2 measurements must be taken ≥ 2 days apart] during the 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% at screening
• Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) 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, 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 agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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229 participants in 2 patient groups

Molidustat group

Experimental group

Description:

Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.

Treatment:

Drug: Molidustat (BAY85-3934)

Drug: Placebo of Darbepoetin alfa

Darbepoetin alfa group

Active Comparator group

Description:

Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.

Treatment:

Drug: Darbepoetin alfa

Drug: Placebo of Molidustat (BAY85-3934)