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Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

NCT01414075 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-01

Study results available
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Summary

The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.

Conditions

Interventions

DRUG

Roxadustat

Tiered, weight-based dosing per schedule specified in the arm.

DRUG

Oral Iron

Administered per oral dose and schedule specified in the arm.

DRUG

IV Iron

Administered per IV dose and schedule specified in the arm.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-21
Primary Completion
2013-01-10
Completion
2013-01-10

Countries

  • United States
  • Hong Kong
  • Russia
  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT01414075 on ClinicalTrials.gov