Phase 1
N=13
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
End-Stage Renal Disease (ESRD)
Bottom Line
View on ClinicalTrials.gov: NCT06468826 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of Avacopan — 105; 86.7; 108 nanograms per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Avacopan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Avacopan |
105; 86.7; 108 | — |
| PRIMARY Cmax of Metabolite M1 |
25.6; 17.2; 16.8 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Avacopan |
838; 661; 945 | — |
| PRIMARY AUClast of Metabolite M1 |
456; 277; 292 | — |
| PRIMARY AUC From Time Zero to Infinity (AUCinf) of Avacopan |
922; 666; NA | — |
| PRIMARY AUCinf of Metabolite M1 |
545; 343; 422 | — |
| PRIMARY AUC From Time Zero to 48 Hours (AUC0-48) of Avacopan |
760; 599; 656 | — |
| PRIMARY AUC0-48 of Metabolite M1 |
349; 236; 230 | — |
| PRIMARY Dialysate Clearance (CLD) of Avacopan |
NA | — |
| PRIMARY CLD of Metabolite M1 |
NA | — |
| SECONDARY Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) |
2; 2; 0 | — |
| SECONDARY Number of Participants Who Experienced Serious Adverse Events (SAEs) |
0; 0; 0 | — |
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 Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT06468826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.