Overview

Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease

Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
KBP Biosciences
Treatments:
Mineralocorticoid Receptor Antagonists
Mineralocorticoids
Polystyrene sulfonic acid