Clinical trial NCT04484857: Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Official title: Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia Associated With End Stage Renal Disease
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2020-07-24
Enrollment: 283
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 study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.


Eligibility criteria: Key Inclusion Criteria:

* Receiving chronic dialysis for end stage renal disease (ESRD)
* Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter
* Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: \< 10.0 g/dL
* Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
* Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment.
* Body weight between 45.0 to 160.0 kg

Key Exclusion Criteria:

* Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
* Known history of myelodysplastic syndrome or multiple myeloma
* Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
* Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
* Active or chronic gastrointestinal bleeding
* Treated with iron-chelating agents within 4 weeks prior to enrollment
* History of New York Heart Association (NYHA) Class III or IV congestive heart failure
* History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
* Uncontrolled hypertension, in the opinion of the Investigator
* Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)
* History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps

Primary outcomes:
measure: Percentage of Participants With Mean Hb Value ≥10 g/dL
timeFrame: Week 16 through Week 24
measure: Mean Hb Change From Baseline to Average Hb From Weeks 16-24
timeFrame: Baseline, Weeks 16-24
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska
state: Alaska
city: Pine Bluff
country: United States
facility: Investigator Site
state: Arkansas
city: Cerritos
country: United States
facility: Investigational Site
state: California
city: Victorville
country: United States
facility: Investigational Site
state: California
city: Denver
country: United States
facility: Investigational Site
state: Colorado
city: Hartford
country: United States
facility: Investigational Site
state: Connecticut
city: Coral Gables
country: United States
facility: Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Investigational Site
state: Florida
city: Dalton
country: United States
facility: Investigator Site
state: Georgia
city: Statesboro
country: United States
facility: Investigational Site
state: Georgia
city: Roseville
country: United States
facility: Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Gallup
country: United States
facility: Investigator Site
state: New Mexico
city: Bronx
country: United States
facility: Investigational Site
state: New York
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigator Site
state: Texas
city: El Paso
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigator Sites
state: Texas
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
Study officials:
affiliation: FibroGen
name: Mark Eisner
role: STUDY_CHAIR
References: