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A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

NCT01750190 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 922

Last updated 2021-10-01

Study results available
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Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

Conditions

  • CKD Anemia

Interventions

DRUG

Roxadustat

Oral tablets

DRUG

Placebo

Oral tablets

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Mark Eisner, MD, MPH · FibroGen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-05
Primary Completion
2018-09-24
Completion
2018-09-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • Colombia
  • Hong Kong
  • Malaysia
  • Mexico
  • New Zealand
  • Peru
  • Philippines
  • Puerto Rico
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
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 NCT01750190 on ClinicalTrials.gov