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Chronic Kidney FailurePhase 1NCT07348237

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

A Phase 1 study testing MK-2828 in people with Chronic Kidney Failure and End-Stage Renal Disease, run by Merck Sharp & Dohme LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 85 yearsHealthy volunteers can take part
What is being tested?
MK-2828
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesUnited States
Study dates
2 Mar 2026to 1 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 locations and contacts

3 sites in 1 country.

United States3 sites

  • Panax Clinical Research ( Site 0003)

    Miami Lakes, Florida, 33014

  • Floridian Clinical Research ( Site 0001)

    Miami Lakes, Florida, 33016

  • Orlando Clinical Research Center ( Site 0002)

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: 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.

Being tested
MK-2828
Medical subject headings
Kidney Failure, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-2828Drug

    Oral administration

Study groups in NCT07348237
Study groupRoleWhat they receive
Severe Renal ImpairmentExperimentalParticipants with severe renal impairment will receive a single dose of MK-2828 on Day 1
Receives: Drug: MK-2828
End Stage Renal Disease (ESRD) on Hemodialysis (HD)ExperimentalParticipants 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.
Receives: Drug: MK-2828
Healthy Mean Matched ControlExperimentalParticipants with normal renal function will receive a single dose of MK-2828 on Day 1
Receives: Drug: MK-2828

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

  4. Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma

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

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

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

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

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

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

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

    Measured: At designated time points up to 24 hours post dose

  7. 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

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

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

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

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

  9. 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

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

Secondary outcomes (7)

  1. 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.

    Measured: Up to approximately 14 days

  2. 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.

    Measured: Up to approximately 2 days

  3. 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

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

  4. 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

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

  5. 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

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

  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

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

  7. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start2 Mar 2026
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07348237
Sponsor's protocol ID
2828-006
Other IDs
MK-2828-006
Status last verified
Sep 2026
First submitted
9 Jan 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-2828 in people with Chronic Kidney Failure and End-Stage Renal Disease, run by Merck Sharp & Dohme LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma (time frame: Pre dose and at designated time points up to 192 hours post dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07348237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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