MK-2828 dosing in people with kidney disease

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

This trial will test how one or two doses of MK-2828 move through the bodies of people with different levels of kidney disease compared with healthy people.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 24 Years to 85 Years
• Sex: All
• Sponsor: Merck Sharp & Dohme LLC (Industry-sponsored)
• Locations: 3 sites (Miami Lakes, Florida and 2 other locations)
• Trial ID: NCT07348237 on ClinicalTrials.gov

What this trial studies

This Phase 1 pharmacokinetic (PK) study measures MK-2828 blood levels over time after one or two doses in participants with severe renal impairment, participants with end-stage renal disease (ESRD) on hemodialysis, and matched healthy controls. The study enrolls people with eGFR < 30 mL/min who are not on hemodialysis, people on a stable outpatient hemodialysis regimen for more than three months, and generally healthy matched controls. Serial blood sampling and PK analysis will compare drug exposure, clearance, and other PK parameters across groups, with attention to timing around dialysis sessions for the ESRD cohort. The trial is conducted at outpatient clinical research centers in Florida and is sponsored by Merck Sharp & Dohme LLC.

Who should consider this trial

Good fit: Ideal candidates are adults in generally good health except for those with stable chronic kidney disease, including people with severe renal impairment (eGFR < 30 mL/min not on dialysis) and people with ESRD on a stable outpatient hemodialysis regimen for more than three months, plus matched healthy controls.

Not a fit: Because this is a Phase 1 PK study, participants should not expect direct therapeutic benefit and people with unstable medical or psychiatric conditions that could confound results are unlikely to be eligible.

Why it matters

Potential benefit: If successful, the results could help guide safe dosing and scheduling of MK-2828 for people with impaired kidney function.

How similar studies have performed: Pharmacokinetic studies in people with renal impairment are a standard and effective way to inform dosing for many drugs, though MK-2828-specific data in this population are limited.

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.

Where this trial is running

Miami Lakes, Florida and 2 other locations

• Panax Clinical Research ( Site 0003) — Miami Lakes, Florida, United States (Recruiting)
• Floridian Clinical Research ( Site 0001) — Miami Lakes, Florida, United States (Recruiting)
• Orlando Clinical Research Center ( Site 0002) — Orlando, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Toll Free Number

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