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Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis

NCT02273726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 741

Last updated 2021-10-29

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.

Conditions

  • CKD Anemia in Stable Dialysis Patients

Interventions

DRUG

Epoetin Alfa

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

DRUG

Roxadustat

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

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Meraf Eyassu · FibroGen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2018-09-19
Completion
2018-09-19
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

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 NCT02273726 on ClinicalTrials.gov