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

Conditions

• End-Stage Renal Disease (ESRD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Avacopan — DRUG
  Oral capsules

Study Details

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).

Key Dates

Start date

Jun 18, 2024

Status verified

Mar 2026

Primary completion

Oct 5, 2024

Completion

Oct 5, 2024

Study Design

Enrollment

13 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Group 1: Normal Renal Function
  Participants in Group 1 will receive a single dose of avacopan on Day 1.
• Experimental: Group 2: ESRD Requiring HD
  Participants in Group 2 will receive a single dose of avacopan on Day 1 in each of 2 treatment periods (Period 1/on HD and Period 2/off HD).

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Avacopan [ Time Frame: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose ]

Locations (2)

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