Conditions: Chronic Kidney Disease
Keywords: CKD CKD, Stage 3 CKD, Stage 4 Vadadustat pharmacokinetics
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.

Detailed description:

Arms:
arm 1: Participants with Stage 3 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate \[eGFR\] 30 - 59 milliliters \[mL\]/minute) received a single 500 milligram (mg) oral dose of Vadadustat after fasting for at least 4 hours. arm 2: Participants with Stage 4 CKD (eGFR \<30 mL/minute and not yet on dialysis) received a single 500 mg oral dose of Vadadustat after fasting for at least 4 hours.

Interventions: intervention 1: Vadadustat
Intervention descriptions: intervention 1: oral capsules

Protocol document: