At a glance
ClinicalIndex Comparison Record- ✓Age 18–75 years
- ✓BMI 19–42 kg/m²
- ✓Severe CKD with eGFR ≥15 and ≤29 mL/min/1.73 m² (non-HD patients only)
- ✓Serum potassium 3.3–4.8 mmol/L at Screening and Check-in (non-HD patients only)
- ✕Clinically significant cardiovascular, pulmonary, hepatic, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease that would compromise safety or interfere with trial results
- ✕History of clinically significant hypotension in prior 6 months
- ✕Symptomatic intradialytic hypotension (HD patients only)
- ✕History of clinically significant hyperkalemia on ACE inhibitor, ARB, direct renin inhibitor, or MRA
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating KBP-5074 for Chronic Kidney Disease. Completed, enrolled 11 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.