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

Phase 2

Completed

• Conditions: Chronic Kidney Disease; End Stage Renal Disease; Anemia
• Interventions: Drug: Roxadustat

• Registration Number: NCT01630889
• Lead Sponsor: FibroGen

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-05-18
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Disposition First Submitted: 2020-06-25
• Disposition First Submitted QC: 2020-06-25
• Disposition First Posted: 2020-06-29
• Status Verified: 2021-09
• Results First Submitted: 2021-09-01
• Results First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Minimum age 18 years
2. Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.

Exclusion Criteria

1. Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study
2. Pregnant or breastfeeding females
3. 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
4. Participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment
5. 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Roxadustat	Roxadustat	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hb Over Time	Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Hb ≥10 g/dL	Baseline up to Week 384	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.
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	Baseline up to Week 384	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.
Number of Participants With Dose Adjustments up to Week 52	Baseline up to Week 52	Dose adjustments include dose increases, dose interruptions, and dose reductions.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Baseline up to Week 385	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.

Trial Locations

Locations (5)

CAIMED School of Medicine; 🇵🇷 Ponce, Puerto Rico

Consolidated Medical Plaza; 🇵🇷 Caguas, Puerto Rico

Mountain Kidney & HTN Associates, PA; 🇺🇸 Asheville, North Carolina, United States

APEX Research; 🇺🇸 Riverside, California, United States

Arlington Nephrology; 🇺🇸 Arlington, Texas, United States