Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants (ASPEN)

FibroGen

Status and phase: Completed; Phase 3

Conditions: Anemia Associated With End Stage Renal Disease

Treatments: Drug: Roxadustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT04484857

FGCL-4592-096

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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283 participants in 1 patient group

Roxadustat

Experimental group

Description:

Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant require roxadustat \<60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency will be reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an ESA, the initial roxadustat dose will be based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta \[Mircera®\]). For participants with \<6 weeks of prior ESA use, the initial roxadustat dose will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower.

Treatment:

Drug: Roxadustat