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Kidney health may change how this drug works

NCT ID NCT06814119

Knowledge-focused Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the drug calderasib (MK-1084) behaves in people with moderate or severe kidney problems compared to healthy volunteers. Researchers will measure drug levels in the blood after a single dose to see if kidney function changes how the body processes it. The study also checks for side effects. 34 adults took part, and the results will help guide future dosing for patients with kidney impairment.

What this could mean

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

Active substance
calderasib (MK-1084) oral tablet
What this could lead to
If successful, this study could help doctors determine the right dose of calderasib for people with kidney problems, making the drug safer and more effective for them.
What could go wrong
This is a very early (Phase 1) study with only 34 participants, so results may not apply to everyone. It only looks at a single dose, not long-term use, and kidney impairment may affect the drug differently than expected.

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

34 people

The number who actually took part.

Started

Apr 2025

Finished

Feb 2026

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.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: All participants: \- Has a BMI ≥18.0 and ≤40.0 kg/m\^2 Participants with severe or moderate RI: * With the exception of RI, is sufficiently healthy for study participation * Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year Participants with normal renal function: \- Is medically healthy Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants: * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus * Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing Participants with severe or moderate RI: * Has a history or presence of renal artery stenosis * Has a renal transplant or nephrectomy

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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.

Healthy Renal impairment

Contacts and locations

Locations

  • Orlando Clinical Research Center ( Site 0002)

    Orlando, Florida, 32809, United States

  • Research by Design ( Site 0001)

    Chicago, Illinois, 60643, United States

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