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NCT Number: NCT07348237

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

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.

Recruiting

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Key information

Age range

24 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Floridian Clinical Research ( Site 0001), Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-2828

Drug

Oral administration

Primary outcomes

  1. Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the AUC0-inf of MK-2828

  2. Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the AUC0-last of MK-2828

  3. Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 24 hours post dose

    Blood samples will be collected to determine the AUC0-24 of MK-2828

  4. Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the Cmax of MK-2828

  5. Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the Tmax of MK-2828

  6. Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma

    Time frame: At designated time points up to 24 hours post dose

    Blood samples will be collected to determine the C24 of MK-2828

  7. Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the t1/2 of MK-2828

  8. Apparent Total Plasma Clearance (CL/F) of MK-2828

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the CL/F of MK-2828

  9. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of MK-2828 in Plasma

    Time frame: Pre dose and at designated time points up to 192 hours post dose

    Blood samples will be collected to determine the Vz/F of MK-2828

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 14 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  2. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 2 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  3. Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828

    Time frame: Prior to hemodialysis (HD) and at designated time points until day 6

    Blood samples will be collected to determine the AUCD of MK-2828

  4. Area Under the Concentration-time Curve Determined from the Pre-dialyzer Line (AUCCa) of MK-2828

    Time frame: Prior to hemodialysis (HD) and at designated time points until day 6

    Blood samples will be collected to determine the during AUCCa of MK-2828 during the dialysis period

  5. Area Under the Concentration-time Curve Determined from the Post-dialyzer Line (AUCCv) of MK-2828

    Time frame: Prior to hemodialysis (HD) and at designated time points until day 6

    Blood samples will be collected to determine the during AUCCv of MK-2828 during the dialysis period

  6. Dialysis Clearance (CLD) of MK-2828 Based on Plasma

    Time frame: Prior to hemodialysis (HD) and at designated time points until day 6

    Blood samples will be collected to determine the CLD of MK-2828 based on plasma during the dialysis period

  7. Hemodialysis Extraction Ratio (ER_D) of MK-2828

    Time frame: Prior to hemodialysis (HD) and at designated time points until day 6

    Blood samples will be collected to determine the ER_D of MK-2828 during the dialysis period

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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