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Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis

NCT01147666 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2022-01-11

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.

Conditions

Interventions

DRUG

Roxadustat

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

DRUG

Epoetin Alfa

Epoetin Alfa will be administered per dose and schedule specified in the arms.

OTHER

Placebo

Placebo matching to roxadustat will be administered per schedule specified in the arm.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Marietta Franco · FibroGen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-17
Primary Completion
2012-10-15
Completion
2012-10-15

Countries

  • United States

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 NCT01147666 on ClinicalTrials.gov