Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
Completed · Phase 2
Conditions studied: Chronic Kidney Disease, End Stage Renal Disease, Anemia
In brief
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.
Key facts
- Study ID
- NCT01630889
- Run by
- Kyntra Bio
- People needed
- 15
- Starts
- 2012-05-18
- Expected to finish
- 2019-12-12
- Last updated by the study team
- 2021-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Minimum age 18 years
- Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.
You may not qualify if…
- Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study
- Pregnant or breastfeeding females
- Females of childbearing potential, unless using adequate contraception; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use adequate contraception
- Participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment
- Any medical condition that in the opinion of the investigator may pose a safety risk to a participant in this study or which may interfere with study participation
Where it is running
- APEX Research — Riverside, California, United States
- Study site — 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
- Study site — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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