How does severe kidney disease affect a new Drug's levels?
NCT ID NCT06814132
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 Hide 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.
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.
- Does it matter where you inject? scientists test Weight-Loss drug in arm, thigh, and belly
- New drug RO7830698 put to the test for COPD
- Three pill versions of one drug go head to head in the bloodstream
- Fewer dialysis sessions: can Twice-Weekly work as well?
- Can pedaling through dialysis make patients stronger?
- Does better dialysis keep parathyroid hormone in check?