Status:
RECRUITING
A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Kidney Failure
End-Stage Renal Disease
Eligibility:
All Genders
24-85 years
Phase:
PHASE1
Brief 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 type...
Eligibility Criteria
The main inclusion criteria include but are not limited to the following:
- 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
The main exclusion criteria include but are not limited to the following:
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.
Key Trial Info
Start Date :
March 2 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07348237
Start Date
March 2 2026
End Date
August 18 2026
Last Update
April 2 2026
Active Locations (3)
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1
Panax Clinical Research ( Site 0003)
Miami Lakes, Florida, United States, 33014
2
Floridian Clinical Research ( Site 0001)
Miami Lakes, Florida, United States, 33016
3
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States, 32809