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A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects (MIYABI HD-C)

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Bayer

Status and phase

Completed
Phase 3

Conditions

Anemia
Renal Insufficiency, Chronic

Treatments

Drug: Molidustat (BAY85-3934)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)

Enrollment

25 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly
  • Body weight > 40 and ≤ 160 kg at screening
  • Male or female subject ≥ 20 years of age at screening
  • At least one kidney
  • Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol
  • Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment
  • 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Molidustat (BAY85-3934)
Experimental group
Description:
Molidustat group
Treatment:
Drug: Molidustat (BAY85-3934)

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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