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

NCT07348237 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2828-006MK-2828-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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 types of kidney disease is similar to the PK of healthy people.

Conditions

Chronic Kidney Failure; End-Stage Renal Disease; Renal Impairment

Outcome Measures

Primary Outcomes (9)

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

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

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

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

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

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

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

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

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

• Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma

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

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

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

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

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

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

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

  At designated time points up to 24 hours post dose

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

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

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

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

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

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

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

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

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

Secondary Outcomes (7)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 14 days

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to approximately 2 days

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

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

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

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

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

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

Study Arms (3)

Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1

Drug: MK-2828

End Stage Renal Disease (ESRD) on Hemodialysis (HD)

EXPERIMENTAL

Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses.

Drug: MK-2828

Healthy Mean Matched Control

EXPERIMENTAL

Participants with normal renal function will receive a single dose of MK-2828 on Day 1

Drug: MK-2828

Interventions

MK-2828 DRUG

Oral administration

End Stage Renal Disease (ESRD) on Hemodialysis (HD); Healthy Mean Matched Control; Severe Renal Impairment

Eligibility Criteria

• Age: 24 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Panax Clinical Research ( Site 0003)

Miami Lakes, Florida, 33014, United States

RECRUITING

Floridian Clinical Research ( Site 0001)

Miami Lakes, Florida, 33016, United States

RECRUITING

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, 32809, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)