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Kidney health may change how body handles experimental drug ESK-001

NCT ID NCT06962774

Knowledge-focused Sponsor: Alumis Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 1 study looked at how different levels of kidney function affect the way the body processes a single dose of ESK-001, an experimental drug. Sixteen participants with healthy kidneys or mild, moderate, or severe kidney impairment each took one oral dose. Researchers measured drug levels in the blood and monitored for side effects to understand how the kidneys impact the drug's breakdown and removal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ESK-001
What this could lead to
If successful, this study will help determine the right dose of ESK-001 for people with kidney problems, making future treatments safer and more effective.
What could go wrong
This is a very early, small study (16 people) focused on drug levels, not on treating any disease. It only looks at a single dose, so long-term effects or benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Apr 2025

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria for All Participants: * Body mass index between 18.0 and 40.0 kg/m2 Key Inclusion Criteria for Participants with Renal Impairment: * Diagnosis of chronic, stable renal function in the 6 months prior to dosing, as determined by the investigator, based on medical history or eGFR, and not requiring dialysis Key Exclusion Criteria for All Participants: * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed). Key Exclusion Criteria for Participants with normal Renal function: -Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee. Key Exclusion Criteria for Participants with Renal Impairment: \- History of any uncontrolled or unstable hepatic, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.

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Conditions

The condition(s) this trial relates to.

impaired renal function disease kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal impairment

Contacts and locations

Locations

  • Advanced Pharma CR

    Miami, Florida, 33147, United States

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014, United States

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