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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630889
• Other study ID #: FGCL-4592-059
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2012
• Est. completion date: December 12, 2019

Study information

• Verified date: September 2021
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Roxadustat
Oral capsule

Locations

Country	Name	City	State
Puerto Rico	Consolidated Medical Plaza	Caguas
Puerto Rico	CAIMED School of Medicine	Ponce
United States	Arlington Nephrology	Arlington	Texas
United States	Mountain Kidney & HTN Associates, PA	Asheville	North Carolina
United States	APEX Research	Riverside	California

Sponsors (3)

Lead Sponsor	Collaborator
FibroGen	Astellas Pharma Inc, AstraZeneca

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])		Baseline up to Week 385
Secondary	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
Secondary	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
Secondary	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