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Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease
The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.
This is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis CKD who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study. Participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
APEX Research
Riverside, California, United States
Greenbelt, Maryland, United States
Mountain Kidney & HTN Associates, PA
Asheville, North Carolina, United States
Arlington Nephrology
Arlington, Texas, United States
Consolidated Medical Plaza
Caguas, Puerto Rico
CAIMED School of Medicine
Ponce, Puerto Rico
San Juan, Puerto Rico
Start Date
May 18, 2012
Primary Completion Date
December 12, 2019
Completion Date
December 12, 2019
Last Updated
October 1, 2021
15
ACTUAL participants
Roxadustat
DRUG
Lead Sponsor
Kyntra Bio
Collaborators
NCT07241390
NCT05012111
Data Source & Attribution
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