Clinical trial NCT04410198: Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
Official title: A Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From a Continuous Erythropoietin Receptor Activator (CERA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients - DENALI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia Associated With End Stage Renal Disease (ESRD)
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2020-06-01
Enrollment: 203
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 chronic dialysis participants converted from 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 tunneled catheter
* Screening hemoglobin criteria (based on central lab value; measured within 10 days prior to initiating Roxadustat treatment: Participants converting from CERA: screening heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment: \<10.0 g/dL
* Ferritin ≥ 50 nanograms (ng)/milliliter (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 (MI), 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
* Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment
* 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: Englewood
country: United States
facility: Investigational Site
state: Colorado
city: Caldwell
country: United States
facility: Investigational Site
state: Idaho
city: Baton Rouge
country: United States
facility: Investigational Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Investigational Site
state: Michigan
city: Tupelo
country: United States
facility: Investigational Site
state: Mississippi
city: Saint Ann
country: United States
facility: Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Sugar Land
country: United States
facility: Investigational Site
state: Texas
city: Saint George
country: United States
facility: Investigational Site
state: Utah
Study officials:
affiliation: FibroGen
name: Mark Eisner
role: STUDY_CHAIR
References: