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Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

NCT03263091 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2024-08-01

Study results available
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Summary

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.

Conditions

  • Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)
  • Anemia

Interventions

DRUG

Roxadustat

Oral tablets

DRUG

Placebo

Oral tablets

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-29
Primary Completion
2023-03-09
Completion
2023-06-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Poland
  • Russia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03263091 on ClinicalTrials.gov