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

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment this month; Phase 1

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

Treatments: Drug: MK-2828

Study type: Interventional

Funder types: Industry

Identifiers

NCT07348237

2828-006

MK-2828-006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 24 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: MK-2828

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

Experimental group

Description:

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.

Treatment:

Drug: MK-2828

Healthy Mean Matched Control

Experimental group

Description:

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

Treatment:

Drug: MK-2828