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Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants

NCT04410198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2022-09-13

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 chronic dialysis participants converted from ESA therapy or who are ESA-naïve.

Conditions

  • Anemia Associated With End Stage Renal Disease (ESRD)

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
2020-05-26
Primary Completion
2021-06-30
Completion
2021-10-11
FDA Drug
Yes

Countries

  • United States

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 NCT04410198 on ClinicalTrials.gov