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

Chronic Kidney Disease Clinical Trial

Official title:
A Phase 1, Open-Label Study in Hemodialysis and Non-Hemodialysis Patients With Severe Chronic Kidney Disease to Evaluate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02837237
Study type Interventional
Source KBP Biosciences
Contact
Status Completed
Phase Phase 1
Start date July 13, 2016
Completion date June 30, 2017
View Details
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