NCT06468826

A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Avacopan in Subjects With Normal Renal Function and Subjects With End-Stage Renal Disease (ESRD) Requiring Hemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring hemodialysis (HD).

Conditions

• End-Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	Avacopan	Oral capsules

Timeline

• Start date: 2024-06-18
• Primary completion: 2024-10-05
• Completion: 2024-10-05
• First posted: 2024-06-21
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study