Conditions: Anemia Chronic Kidney Disease
Keywords: anemia chronic kidney disease CKD chronic renal insufficiency renal impairment erythropoietin kidney oral anemia treatment hemoglobin hypoxia-inducible factor HIF hypoxia-inducible factor prolyl-hydroxylase inhibitor HIF-PHI efficacy safety pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 210
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 Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: AKB-6548 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. intervention 2: Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Protocol document: