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A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)

RecruitingPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Chronic Kidney Failure, End-Stage Renal Disease, Renal Impairment

Interventions: MK-2828

Countries: United States

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 overview

Sex: ALL

Age: 24 Years to 85 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (3)

Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States