Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease, End Stage Renal Disease, Anemia

Intervention / Treatment
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* Drug: Roxadustat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Roxadustat<br>Participants previously randomized to roxadustat will receive roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments will be implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experiences an event of excessive hematopoiesis then the participant's dose will be immediately reduced, or an event of rapidly declining Hb then the participant's dose will be immediately increased. Participants will be permitted to receive roxadustat for up to 8 years. | Drug: Roxadustat<br>* Oral capsule<br>* Other names: FG-4592;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hb Over Time | Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as over time for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure. | Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hb ≥10 g/dL | Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. | Baseline up to Week 384 | 
| Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA]) |  | Baseline up to Week 385 | 
| Mean Weekly Dose of Study Drug Over Time | Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2. | Baseline up to Week 384 | 
| Number of Participants With Dose Adjustments up to Week 52 | Dose adjustments include dose increases, dose interruptions, and dose reductions. | Baseline up to Week 52 | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline up to Week 385 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal, Kidney, ESRD, End Stage Renal Disease, Anemia, Oral anemia treatment, Hemoglobin levels, Hemodialysis, CKD, Chronic Kidney Disease, HD, PD, Hb, Erythropoietin, Blood count