An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · Single · Treatment
Enrollment
16actual
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-23 | actual | When the study began enrolling |
| Primary completion | 2025-08-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-01 | actual | The whole study's end, after follow-up |
| First posted | 2025-05-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Renal Impairment
Intervention
- Drug: ESK-001
Primary outcomes
what the primary-completion date above is the date OFMaximum observed plasma concentration (Cmax)
measured 48 hours
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
measured 48 hours
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
measured 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
measured 48 hours
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