RecruitingPhase 1NCT07348237
A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment
Sponsor
Merck Sharp & Dohme LLC
Enrollment
24 participants
Start Date
Mar 2, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.
Eligibility
Min Age: 24 YearsMax Age: 85 Years
Inclusion Criteria5
- Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor.
- Severe Renal Impairment Participants:
- Has an estimated glomerular filtration rate (eGFR) \< 30 mL/min), but is not on hemodialysis (HD)
- ESRD on HD Participants:
- Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for \> 3 months prior to study entry
Exclusion Criteria4
- Renal Impairment Participants:
- History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Healthy Matched Control Participants:
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Interventions
DRUGMK-2828
Oral administration
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07348237
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