Phase 2
Completed N=15
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01630889 ↗Enrolled (actual)
15
Serious AEs
60.0%
Results posted
Oct 2021
Primary outcomePrimary: Change From Baseline in Hb Over Time — 10.05; 1.26; 1.58; 1.94 g/dL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hb Over Time |
10.05; 1.26; 1.58; 1.94; 2.54; 1.18 | — |
| SECONDARY Number of Participants With Hb ≥10 g/dL |
9; 13; 13; 13; 11; 7 | — |
| SECONDARY Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA]) |
1; 5; 1; 8 | — |
| SECONDARY Mean Weekly Dose of Study Drug Over Time |
257.0; 252.4; 282.3; 318.4; 236.7; 155.9 | — |
| SECONDARY Number of Participants With Dose Adjustments up to Week 52 |
1; 5; 1; 6; 1; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
14; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Minimum age 18 years
- Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01630889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.