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

NCT ID: NCT07348237

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-24

Study Completion Date

2026-08-18

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Failure End-Stage Renal Disease Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Severe Renal Impairment

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

Group Type EXPERIMENTAL

MK-2828

Intervention Type DRUG

Oral administration

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.

Group Type EXPERIMENTAL

MK-2828

Intervention Type DRUG

Oral administration

Healthy Mean Matched Control

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

Group Type EXPERIMENTAL

MK-2828

Intervention Type DRUG

Oral administration

Interventions

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MK-2828

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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.
Minimum Eligible Age

24 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-2828-006

Identifier Type: OTHER

Identifier Source: secondary_id

2828-006

Identifier Type: -

Identifier Source: org_study_id

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