Conditions: Chronic Kidney Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis \[HD\]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular filtration rate \[eGFR\] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification of Diet in Renal Disease \[MDRD\] equation) and a subset of patients requiring HD.

Detailed description:
This is a Phase 1, multicenter, open-label, 2-part study designed to assess the PK, safety, and tolerability of KBP-5074 in patients undergoing HD and non-HD patients with severe CKD (defined using the eGFR ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2 based on the MDRD equation). The study will be conducted at up to 4 clinical research units (CRUs) in the US. Approximately 12 patients will be enrolled in the study (a single cohort of 6 patients in each of Part 1 and Part 2). Parts 1 and 2 of the study will be conducted in parallel. If Part 1 is completed prior to the completion of Part 2, or vice versa, the PK, safety, and tolerability analyses for the completed study part may proceed as planned and will not be delayed based on the timing of the other respective study part.

Arms:
arm 1: Single oral dose

Interventions: intervention 1: KBP-5074
Intervention descriptions: intervention 1: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.

In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.

Protocol document: