Maintenance Treatment of Renal Anemia in Dialysis Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03543657
• Date of registration: 22/05/2018
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Maintenance Treatment of Renal Anemia in Dialysis Subjects MIYABI HD-M
• Scientific title: A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)
• Date of first enrolment: June 23, 2018
• Target sample size: 229
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03543657
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Insufficiency, Chronic

Anemia

Intervention(s)

Drug: Molidustat (BAY85-3934)

Drug: Placebo of Darbepoetin alfa

Drug: Darbepoetin alfa

Drug: Placebo of Molidustat (BAY85-3934)

Primary Outcome(s)

The change in mean Hb level during the evaluation period from baseline [Time Frame: Baseline and week 33 to 36]

The mean Hb level during the evaluation period [Time Frame: From week 33 to 36]

Secondary Outcome(s)

Maximum concentration (Cmax) [Time Frame: At baseline, week 8, week 24 and week 52]

Proportion of subjects whose mean hemoglobin level is above the target range [Time Frame: From week 33 to 36]

Hb level [Time Frame: Up to 52 weeks]

Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week [Time Frame: Up to 52 weeks]

Change in Hb level [Time Frame: Baseline and up to 52 weeks]

Number of participants with serious adverse events [Time Frame: Up to 52 weeks]

Proportion of subjects whose mean hemoglobin level is in the target range [Time Frame: From week 33 to 36]

Proportion of subjects who meet each component of the response [Time Frame: From week 33 to 36]

Proportion of subjects with hemoglobin levels below the target range [Time Frame: Up to 52 weeks]

Area under the concentration-time curve (AUC) [Time Frame: At baseline, week 8, week 24 and week 52]

EPO (Erythropoietin) serum concentration [Time Frame: At baseline, week 8, week 24 and week 52]

Proportion of subjects with hemoglobin levels in the target range [Time Frame: Up to 52 weeks]

Proportion of subjects whose mean hemoglobin level is below the target range [Time Frame: From week 33 to 36]

Proportion of subjects with hemoglobin levels above the target range [Time Frame: Up to 52 weeks]

Responder rate: proportion of responders among the subjects [Time Frame: From week 33 to 36]

Secondary ID(s)

19352

Source(s) of Monetary Support

Please refer to primary and secondary sponsors