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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Impairment; End-Stage Renal Disease; Chronic Kidney Failure
• Intervention / Treatment: Drug: MK-2828

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@msd.com

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Recruiting
      • Panax Clinical Research ( Site 0003)
      • Contact: Study Coordinator; Phone Number: 305-698-4500
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Floridian Clinical Research ( Site 0001)
      • Contact: Study Coordinator; Phone Number: 305-330-9977
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center ( Site 0002)
      • Contact: Study Coordinator; Phone Number: 407-240-7878

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe Renal Impairment; Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1	Drug: MK-2828; Oral administration
Experimental: End Stage Renal Disease (ESRD) on Hemodialysis (HD); 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; Oral administration
Experimental: Healthy Mean Matched Control; Participants with normal renal function will receive a single dose of MK-2828 on Day 1	Drug: MK-2828; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event (AE)	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.	Up to approximately 14 days
Number of Participants Who Discontinue Study Intervention Due to an AE	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.	Up to approximately 2 days
Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828	Blood samples will be collected to determine the 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	Blood samples will be collected to determine the during AUCCa of MK-2828 during the dialysis period	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	Blood samples will be collected to determine the during AUCCv of MK-2828 during the dialysis period	Prior to hemodialysis (HD) and at designated time points until day 6
Dialysis Clearance (CLD) of MK-2828 Based on Plasma	Blood samples will be collected to determine the CLD of MK-2828 based on plasma during the dialysis period	Prior to hemodialysis (HD) and at designated time points until day 6
Hemodialysis Extraction Ratio (ER_D) of MK-2828	Blood samples will be collected to determine the ER_D of MK-2828 during the dialysis period	Prior to hemodialysis (HD) and at designated time points until day 6

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic
• Other Study ID Numbers: 2828-006; MK-2828-006 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No