End-Stage Renal Disease (ESRD)Phase 1NCT06468826

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

A Phase 1 study testing Avacopan in people with End-Stage Renal Disease (ESRD), run by Amgen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: End-Stage Renal Disease (ESRD)
What is being tested?: Avacopan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 2 sitesUnited States
Study dates: 18 Jun 2024to 5 Oct 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.
Female participants with a positive pregnancy test at Screening or Check-in.
Female participants lactating/breastfeeding or who plan to breastfeed during the study through 60 days after administration of investigational product.
Participants in Group 1 (normal renal function) are excluded if:
History of malignancy of any type, with the exception of the following: in situ cervical cancer or surgically excised non-melanomatous skin cancers more than 5 years before receiving avacopan.
A corrected QT interval by Fredericia (QTcF) >450 msec in males or >470 msec in females or history/evidence of long QT syndrome at Screening or Check-in.
A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile at Screening or Check-in.
Participants in Group 2 (ESRD requiring HD) are excluded if:
Child-Pugh classification of Class C. Child-Pugh will only be evaluated for participants deemed to have active liver disease by the Investigator (or designee).
Active malignancy of any type.
A change in disease status within 30 days of Screening, as documented by the participants medical history, deemed clinically significant by the Investigator.
A QTcF ≥470 msec in males or ≥480 msec in females.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
Orlando Clinical Research Center
Orlando, Florida, 32809-3017

Other trials in United States

About this study

Official title: 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

Conditions: End-Stage Renal Disease (ESRD)
Being tested: Avacopan
Keywords: End-Stage Renal Disease, ESRD, Renal Function, Hemodialysis
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AvacopanDrug
Also called Tavneos, AMG 569, CCX168
Oral capsules

Study groups in NCT06468826
Study group	Role	What they receive
Group 1: Normal Renal Function	Experimental	Participants in Group 1 will receive a single dose of avacopan on Day 1. Receives: 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). Receives: Drug: Avacopan

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Avacopan
Cmax was obtained using noncompartmental analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
An adverse event was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) that was temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAEs was defined as an AE that started during or after first dose administration or started prior to first dose administration and increased in severity after dosing.
Measured: From first dose of study drug to end of study (EOS) (up to 36 days)
Number of Participants Who Experienced Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence that met at least 1 of the following criteria: results in death, is immediately life-threatening, required inpatient hospitalization or prolonged existing hospitalization, persistent or significant incapacity/disability, a congenital abnormality/birth defect, or other medically important serious event.
Measured: From signing the informed consent form (ICF) to 30 days after EOS (up to 96 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 20245 Oct 2024

First posted21 Jun 2024
Study start18 Jun 2024
Primary completion5 Oct 2024
Study completion5 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End-Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06468826
Sponsor's protocol ID: 20230265
Status last verified: Mar 2026
First submitted: 17 Jun 2024
Last updated: 11 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

Mohrmann C, Oberoi RK, Flach SD, Marbury TC, Hernandez P, Gokhale M, MacElrevey CR, Sampson C, Amouzadeh H, Hudson K, Upreti VV, Ward JA. A Phase 1 Study Evaluating the Pharmacokinetics and Safety of Avacopan in Participants with End-Stage Kidney Disease on Hemodialysis. J Clin Pharmacol. 2026 Apr;66(4):e70195. doi: 10.1002/jcph.70195.
PubMed 42030010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06468826
Acronym / sponsor ID: 20230265
Conditions: End-Stage Renal Disease (ESRD)
Keywords: End-Stage Renal Disease, ESRD, Renal Function, Hemodialysis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 18 Jun 2024 (actual)
Primary completion: 5 Oct 2024 (actual)
Study completion: 5 Oct 2024 (actual)
First posted: 21 Jun 2024 (actual)
Results: Posted 25 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Normal Renal Function	Experimental	Drug: AvacopanParticipants in Group 1 will receive a single dose of avacopan on Day 1.
Group 2: ESRD Requiring HD	Experimental	Drug: AvacopanParticipants 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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).

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AvacopanAlso: Tavneos, AMG 569, CCX168Oral capsules	Drug	Group 1: Normal Renal Function, Group 2: ESRD Requiring HD

Primary outcome

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
Cmax was obtained using noncompartmental analysis.
Cmax of Metabolite M1
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
Cmax was obtained using noncompartmental analysis.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) 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
AUClast was obtained using noncompartmental analysis.
AUClast of Metabolite M1
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
AUClast was obtained using noncompartmental analysis.
AUC From Time Zero to Infinity (AUCinf) 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
AUCinf was obtained using noncompartmental analysis.
AUCinf of Metabolite M1
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
AUCinf was obtained using noncompartmental analysis.
AUC From Time Zero to 48 Hours (AUC0-48) of Avacopan
Time frame: 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 was obtained using noncompartmental analysis.
AUC0-48 of Metabolite M1
Time frame: 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 was obtained using noncompartmental analysis.
Dialysate Clearance (CLD) of Avacopan
Time frame: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1
CLD determines how much of the drug is removed by hemodialysis.
CLD of Metabolite M1
Time frame: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1
CLD determines how much of the drug is removed by hemodialysis.

2 secondary outcomes

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug to end of study (EOS) (up to 36 days)
Number of Participants Who Experienced Serious Adverse Events (SAEs)
Time frame: From signing the informed consent form (ICF) to 30 days after EOS (up to 96 days)

Results and safety

Results posted to the registry on 25 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Normal Renal Function	6	6
Group 2: ESRD Requiring HD	7	7

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Group 1: Normal Renal Function n = 6	Group 2; Period 1: ESRD Requiring HD (On-HD) n = 7	Group 2; Period 2: ESRD Requiring HD (Off-HD) n = 7
Value	105 (22.8)	86.7 (51.0)	108 (34.8)

Group 1: Normal Renal Function vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 1.03 (90% CI 0.775 to 1.38)
Group 2; Period 1: ESRD Requiring HD (On-HD) vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 0.800 (90% CI 0.622 to 1.03)

Population analysed: The pharmacokinetic (PK) population included all participants who received at least 1 dose of avacopan and had evaluable PK data.

Primary outcome: Cmax of Metabolite M1

Measure	Group 1: Normal Renal Function n = 6	Group 2; Period 1: ESRD Requiring HD (On-HD) n = 7	Group 2; Period 2: ESRD Requiring HD (Off-HD) n = 7
Value	25.6 (12.6)	17.2 (25.3)	16.8 (24.6)

Group 1: Normal Renal Function vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 0.658 (90% CI 0.549 to 0.787)
Group 2; Period 1: ESRD Requiring HD (On-HD) vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 1.02 (90% CI 0.829 to 1.26)

Population analysed: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.

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

Measure	Group 1: Normal Renal Function n = 6	Group 2: ESRD Requiring HD (On-HD) n = 7	Group 2; Period 2: ESRD Requiring HD (Off-HD) n = 7
Value	838 (44.5)	661 (53.9)	945 (49.0)

Group 1: Normal Renal Function vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 1.12 (90% CI 0.690 to 1.83)
Group 2: ESRD Requiring HD (On-HD) vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 0.699 (90% CI 0.585 to 0.836)

Population analysed: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.

Primary outcome: AUClast of Metabolite M1

Measure	Group 1: Normal Renal Function n = 6	Group 2; Period 1: ESRD Requiring HD (On-HD) n = 7	Group 2; Period 2: ESRD Requiring HD (Off-HD) n = 7
Value	456 (29.2)	277 (21.3)	292 (28.4)

Group 1: Normal Renal Function vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 0.639 (90% CI 0.491 to 0.832)
Group 2; Period 1: ESRD Requiring HD (On-HD) vs Group 2; Period 2: ESRD Requiring HD (Off-HD): Ratio of GLSMs: 0.947 (90% CI 0.825 to 1.09)

Population analysed: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Normal Renal Function	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Group 2; Period 1: ESRD Requiring HD (On-HD)	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Group 2; Period 2: ESRD Requiring HD (Off-HD)	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 42030010Mohrmann C, Oberoi RK, Flach SD, Marbury TC, Hernandez P, Gokhale M, MacElrevey CR, Sampson C, Amouzadeh H, Hudson K, Upreti VV, Ward JA. A Phase 1 Study Evaluating the Pharmacokinetics and Safety of Avacopan in Participants with End-Stage Kidney Disease on Hemodialysis. J Clin Pharmacol. 2026 Apr;66(4):e70195. doi: 10.1002/jcph.70195.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Avacopan in people with End-Stage Renal Disease (ESRD), run by Amgen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06468826, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.