Clinical trial NCT01630889: Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
End Stage Renal Disease
Anemia
Keywords: Kidney
ESRD
End Stage Renal Disease
Anemia
Oral anemia treatment
Hemoglobin levels
Hemodialysis
CKD
Chronic Kidney Disease
Peritoneal
HD
PD
Hb
Erythropoietin
Blood count
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
name: Astellas Pharma Inc
First posted: 2012-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Hb Over Time
timeFrame: Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384
Secondary outcomes:
measure: Number of Participants With Hb ≥10 g/dL
timeFrame: Baseline up to Week 384
measure: Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])
timeFrame: Baseline up to Week 385
measure: Mean Weekly Dose of Study Drug Over Time
timeFrame: Baseline up to Week 384
measure: Number of Participants With Dose Adjustments up to Week 52
timeFrame: Baseline up to Week 52
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Baseline up to Week 385
Other outcomes:
Locations:
city: Riverside
country: United States
facility: APEX Research
state: California
city: Greenbelt
country: United States
state: Maryland
city: Asheville
country: United States
facility: Mountain Kidney & HTN Associates, PA
state: North Carolina
city: Arlington
country: United States
facility: Arlington Nephrology
state: Texas
city: Caguas
country: Puerto Rico
facility: Consolidated Medical Plaza
city: Ponce
country: Puerto Rico
facility: CAIMED School of Medicine
city: San Juan
country: Puerto Rico
Study officials:
affiliation: FibroGen
name: Peony Yu
role: STUDY_DIRECTOR
References: