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

NCT06468826 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20230265
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

End-Stage Renal Disease; ESRD; Renal Function; Hemodialysis

Outcome Measures

Primary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) of Avacopan

  Cmax was obtained using noncompartmental analysis.

  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

• Cmax of Metabolite M1

  Cmax was obtained using noncompartmental analysis.

  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

• Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Avacopan

  AUClast was obtained using noncompartmental analysis.

  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

• AUClast of Metabolite M1

  AUClast was obtained using noncompartmental analysis.

  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

• AUC From Time Zero to Infinity (AUCinf) of Avacopan

  AUCinf was obtained using noncompartmental analysis.

  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

• AUCinf of Metabolite M1

  AUCinf was obtained using noncompartmental analysis.

  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

• AUC From Time Zero to 48 Hours (AUC0-48) of Avacopan

  AUC0-48 was obtained using noncompartmental analysis.

  Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose

• AUC0-48 of Metabolite M1

  AUC0-48 was obtained using noncompartmental analysis.

  Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose

• Dialysate Clearance (CLD) of Avacopan

  CLD determines how much of the drug is removed by hemodialysis.

  Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1

• CLD of Metabolite M1

  CLD determines how much of the drug is removed by hemodialysis.

  Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1

Secondary Outcomes (2)

• Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

  From first dose of study drug to end of study (EOS) (up to 36 days)

• Number of Participants Who Experienced Serious Adverse Events (SAEs)

  From signing the informed consent form (ICF) to 30 days after EOS (up to 96 days)

Study Arms (2)

Group 1: Normal Renal Function

EXPERIMENTAL

Participants in Group 1 will receive a single dose of avacopan on Day 1.

Drug: Avacopan

Group 2: ESRD Requiring HD

EXPERIMENTAL

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).

Drug: Avacopan

Interventions

Avacopan DRUG

Oral capsules

Also known as: Tavneos, AMG 569, CCX168

Group 1: Normal Renal Function; Group 2: ESRD Requiring HD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Group 1 (normal renal function): eGFR ≥90 mL/min and no history of renal disease.
• Group 2 (ESRD requiring HD): eGFR \<15 mL/min and receiving HD.

You may not qualify if:

• 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.
• Participants on the national transplant list (United Network for Organ Sharing) at Screening who anticipate receiving an organ transplant within 4 months.
• Positive human immunodeficiency virus test.
• Positive hepatitis B or hepatitis C panel at Screening. Participants whose results are compatible with prior hepatitis B infection (positive hepatitis B surface antibody, positive hepatitis B core antibody, or negative HBsAg) will be excluded. Participants whose results are compatible with prior hepatitis B vaccination may be included.
• History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
• History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration, or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery, other than uncomplicated appendectomy.

Sponsors & Collaborators

• Amgen: lead

Study Sites (2)

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

avacopan

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: June 18, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (2)