MedTrace Logo

A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects

NCT03350347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

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 non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)

Conditions

  • Anemia
  • Renal Insufficiency, Chronic

Interventions

DRUG

Molidustat (BAY85-3934)

Starting dose of 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response

DRUG

Darbepoetin alfa

Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2019-07-05
Completion
2019-11-28

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 NCT03350347 on ClinicalTrials.gov