Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

How does severe kidney disease affect a new Drug's levels?

NCT ID NCT06814132

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study looked at how the drug MK-5684 behaves in the body of men with severe kidney disease or end-stage renal disease compared to healthy men. Twenty-four participants received a single dose, and researchers measured drug levels in the blood over time. The goal is to understand how kidney function affects the drug's processing, which could guide future dosing recommendations.

What this could mean

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

Active substance
MK-5684 (oral tablet, with prednisone and fludrocortisone acetate)
What this could lead to
If successful, this study could help doctors determine the right dose of MK-5684 for people with severe kidney problems, making treatment safer and more effective.
What could go wrong
This is a small, early-phase study focused on drug levels, not on treating disease. It may not lead to any new treatment, and results may not apply to women or people with milder kidney issues.

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

24 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 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 85 years

Sex

Male participants only

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: Inclusion criteria include, but are not limited to: All Participants * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing * Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m\^2 at the screening visit Participants with severe renal impairment (RI) (Group 1): * Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation Participants with end-stage renal disease (ESRD) (Group 2): * Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit Healthy Control Participants (Group 3): * Has normal renal function Exclusion Criteria: Exclusion criteria include, but are not limited to: All Participants: * Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection * Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome) * Has a history of cancer (malignancy) * Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) Participants with Severe RI (Group 1): * Has a history or presence of renal artery stenosis * Has had a renal transplant * Has ESRD requiring HD Participants with ESRD (Group 2): * Has required frequent emergent HD (≥ 3) within a year prior to the first dosing * Has a history or presence of renal artery stenosis. * Has had a functioning renal transplant within the past 2 years

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for End-stage kidney disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.