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Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants

NCT02052310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1043

Last updated 2021-10-01

Study results available
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Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.

Conditions

  • Anemia in Incident Dialysis Patients

Interventions

DRUG

Roxadustat

Roxadustat will be administered per dose and schedule specified in the arm.

DRUG

Epoetin Alfa

Epoetin alfa will be administered TIW according to the epoetin alfa USPI or SmPC, or local SOC.

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Charles Bradley, PhD · FibroGen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-11
Primary Completion
2018-09-21
Completion
2018-09-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • Colombia
  • Latvia
  • Malaysia
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT02052310 on ClinicalTrials.gov