MedTrace Logo

Maintenance Treatment of Renal Anemia in Dialysis Subjects

NCT03543657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2021-01-29

No results posted yet for this study

Summary

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).

Conditions

  • Anemia
  • Renal Insufficiency, Chronic

Interventions

DRUG

Molidustat (BAY85-3934)

Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).

DRUG

Darbepoetin alfa

Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

DRUG

Placebo of Molidustat (BAY85-3934)

Matching placebo of Molidustat.

DRUG

Placebo of Darbepoetin alfa

Matching placebo of Darbepoetin alfa.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-23
Primary Completion
2019-08-07
Completion
2019-12-24

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543657 on ClinicalTrials.gov