Conditions: Anemia End Stage Renal Disease
Keywords: anemia end stage renal disease chronic kidney disease CKD dialysis chronic renal insufficiency renal impairment erythropoietin kidney oral anemia treatment hemoglobin hypoxia-inducible factor HIF hypoxia-inducible factor propyl-hydroxylase inhibitor HIF-PHI pharmacokinetics
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 94
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: AKB-6548 intervention 2: AKB-6548 intervention 3: AKB-6548
Intervention descriptions: intervention 1: Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. intervention 2: Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. intervention 3: Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.

Protocol document: