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Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants

NCT04484857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2022-07-26

Study results available
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Summary

The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.

Conditions

  • Anemia Associated With End Stage Renal Disease

Interventions

DRUG

Roxadustat

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Mark Eisner · FibroGen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2021-07-09
Completion
2021-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04484857 on ClinicalTrials.gov