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Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

NCT02174731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2133

Last updated 2019-12-16

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.

Conditions

Interventions

DRUG

Roxadustat

Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.

DRUG

Epoetin alfa

Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.

Sponsors & Collaborators

  • FibroGen

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Steven Fishbane, MD · Chief Division of Kidney Diseases and Hypertension, North Shore University Hospital, Great Neck, NY, USA

  • Mark Houser, MD · AZ R&D, Gaithersburg, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2018-09-26
Completion
2018-09-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Hungary
  • India
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Thailand
  • Ukraine
  • Vietnam

Study Locations

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Entities

Diseases
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 NCT02174731 on ClinicalTrials.gov