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Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

NCT01887600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2024-11-14

Study results available
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Summary

This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.

Conditions

  • Anemia in Chronic Kidney Disease in Non-dialysis Patients

Interventions

DRUG

Roxadustat

Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.

DRUG

Placebo

Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-03
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • Belarus
  • Belgium
  • Bulgaria
  • Colombia
  • Dominican Republic
  • Estonia
  • Georgia
  • Greece
  • Guatemala
  • Hungary
  • Italy
  • Panama
  • Peru
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01887600 on ClinicalTrials.gov