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Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

NCT02021318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2024-11-14

Study results available
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Summary

The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.

Conditions

  • Anemia in Chronic Kidney Disease in Non-dialysis Patients

Interventions

DRUG

Roxadustat

Oral tablet.

DRUG

Darbepoetin alfa

Subcutaneous or intravenous injection.

Sponsors & Collaborators

  • FibroGen

    collaborator INDUSTRY

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-12
Primary Completion
2018-03-23
Completion
2019-11-06

Countries

  • Austria
  • Belarus
  • Bulgaria
  • Croatia
  • Czechia
  • Finland
  • France
  • Georgia
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Latvia
  • Montenegro
  • Netherlands
  • North Macedonia
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT02021318 on ClinicalTrials.gov