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A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) | Clinical Trials | Clareo Health

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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

NCT06468826•Amgen

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant has provided informed consent.
•Male or female participants, between 18 and 75 years of age (inclusive) at the time of Screening.
•Body mass index between 18 and \<40 kg/m\^2 at the time of Screening.
•Eligible participants will be classified based on established need for renal replacement therapy and estimated glomerular filtration rate (eGFR).
•1. Group 1 (normal renal function): eGFR ≥90 mL/min and no history of renal disease.
•2. Group 2 (ESRD requiring HD): eGFR \<15 mL/min and receiving HD.

Exclusion Criteria

•All Participants:
•History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, or neurological disease, or evidence of rapidly deteriorating renal function.
•History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
•Total white blood cell count is below the lower limit of normal at Screening or Check-in.
•Significant infection within 28 days before Check-in.
•Prior infection with or exposure to tuberculosis, or travel to areas of endemic tuberculosis or endemic mycoses within the past 6 months.
•Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase or alanine aminotransferase \> the upper limit of normal for Group 1 (normal renal function) and \>2 times the upper limit of normal for Group 2 (ESRD requiring HD).
•History or evidence, at Screening or Check-in, of poorly controlled diabetes (regardless of type), based on hemoglobin A1C of \>10%.
•Clinically significant hyperkalemia (defined by serum potassium concentration as \>5.5 mEq/L for Group 1 \[normal renal function\], \>6 mEq/L for Group 2 \[ESRD requiring HD\]) at Screening or Check-in.
•Participants who have a current, functioning organ transplant and/or are on immunosuppressants.
+16 more criteria

Locations (2)

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Key Dates

Start Date

July 11, 2024

Primary Completion Date

October 5, 2024

Completion Date

October 5, 2024

Last Updated

September 18, 2025

Enrollment

ACTUAL participants

Conditions

End-Stage Renal Disease (ESRD)

Interventions

Avacopan

DRUG

Intracellular Phosphate Concentration Evolution During Hemodialysis by MR Spectroscopy

NCT03119818

End-Stage Renal Disease (ESRD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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