Kidney Failure, ChronicPhase 1NCT06814132

A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)

A Phase 1 study testing MK-5684, Prednisone and Fludrocortisone acetate in people with Kidney Failure, Chronic and End-Stage Kidney Disease, run by Merck Sharp & Dohme LLC at 2 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 the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus… Read more about this study

Who is it for?: Ages 18 to 85 years, men onlyHealthy volunteers can take part
Conditions the study is for: Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic
What is being tested?: MK-5684, Prednisone and Fludrocortisone acetate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 7 Apr 2025to 14 Oct 2025
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 18 to 85 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All Participants
Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing
Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m^2 at the screening visit
Participants with severe renal impairment (RI) (Group 1):
Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
Participants with end-stage renal disease (ESRD) (Group 2):

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Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit
Healthy Control Participants (Group 3):
Has normal renal function

Who cannot join

All Participants:
Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection
Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
Has a history of cancer (malignancy)
Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Participants with Severe RI (Group 1):

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Has a history or presence of renal artery stenosis
Has had a renal transplant
Has ESRD requiring HD
Participants with ESRD (Group 2):
Has required frequent emergent HD (≥ 3) within a year prior to the first dosing
Has a history or presence of renal artery stenosis.
Has had a functioning renal transplant within the past 2 years

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research by Design ( Site 0001)
Chicago, Illinois, 60643
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease

Conditions: Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic, Renal Failure, End-Stage, Healthy Participants
Being tested: MK-5684, Prednisone, Fludrocortisone acetate
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

MK-5684Drug
Oral tablet
PrednisoneDrug
Also called HRT
Oral tablet
Fludrocortisone acetateDrug
Also called HRT
Oral tablet

Study groups in NCT06814132
Study group	Role	What they receive
Group 1: Severe Renal Impairment (RI)	Experimental	Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal). Receives: Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate
Group 2: End-stage renal disease (ESRD)	Experimental	Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) in Period 1 and Period 2. In Period 1, participants will receive a single oral dose of MK-5684 approximately 30 minutes prior to their normally scheduled hemodialysis (HD), followed by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. In Period 2, participants will receive a single oral dose of MK-5684 immediately followed by completion of their normally scheduled HD, and by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. Receives: Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate
Group 3: Healthy Participants	Experimental	Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal). Receives: Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate

What is being measured

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

Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684
Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose
Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684
Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose
Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684
Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 24 hours post-dose
Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684
Blood samples will be collected to determine the Cmax of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose
Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684
Blood samples will be collected to determine the Tmax of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose
Apparent Terminal Half-Life (t½) of MK-5684
Blood samples will be collected to determine the t1/2 of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose
Apparent Clearance (CL/F) of MK-5684
Blood samples will be collected to determine the CL/F of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684
Blood samples will be collected to determine the Vz/F of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 72 hours post-dose

Secondary outcomes (5)

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 the study intervention, whether or not considered related to the study intervention.
Measured: Up to ~21 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 the study intervention, whether or not considered related to the study intervention.
Measured: Up to ~7 days
Dialysis Clearance (CLD) of MK5684 Based on Plasma
Dialysate will be collected to determine the CLD of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 4.5 hours post-dose
Concentration of Dialysate (CD) of MK-5684 Samples
Dialysate will be collected to determine the CD of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 4.5 hours post-dose
Amount of drug (AD) of MK-5684 recovered from each dialysate collection
Dialysate will be collected to determine the AD of MK-5684 in plasma.
Measured: At protocol specific time points pre-dose and up to 4.5 hours post-dose

Timeline

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

7 Apr 202514 Oct 2025

First posted7 Feb 2025
Study start7 Apr 2025
Primary completion4 Oct 2025
Study completion14 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06814132
Sponsor's protocol ID: 5684-010
Other IDs: MK-5684-010, CA43216
Status last verified: Oct 2025
First submitted: 3 Feb 2025
Last updated: 23 Oct 2025
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease
ClinicalTrials.gov ID: NCT06814132
Acronym / sponsor ID: 5684-010
Conditions: Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic, Renal Failure, End-Stage, Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 7 Apr 2025 (actual)
Primary completion: 4 Oct 2025 (actual)
Study completion: 14 Oct 2025 (actual)
First posted: 7 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1: Severe Renal Impairment (RI)	Experimental	Drug: MK-5684, Drug: Prednisone, Drug: Fludrocortisone acetateParticipants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal).
Group 2: End-stage renal disease (ESRD)	Experimental	Drug: MK-5684, Drug: Prednisone, Drug: Fludrocortisone acetateParticipants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) in Period 1 and Period 2. In Period 1, participants will receive a single oral dose of MK-5684 approximately 30 minutes prior to their normally scheduled hemodialysis (HD), followed by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. In Period 2, participants will receive a single oral dose of MK-5684 immediately followed by completion of their normally scheduled HD, and by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing.
Group 3: Healthy Participants	Experimental	Drug: MK-5684, Drug: Prednisone, Drug: Fludrocortisone acetateParticipants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal).

Who may qualify

Ages: 18 to 85 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

All Participants
Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing
Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m^2 at the screening visit
Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit

Key exclusion criteria (13 listed)

Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection
Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
Has a history of cancer (malignancy)
Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Has a history or presence of renal artery stenosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-5684Oral tablet	Drug	Group 1: Severe Renal Impairment (RI), Group 2: End-stage renal disease (ESRD), Group 3: Healthy Participants
PrednisoneAlso: HRTOral tablet	Drug	Group 1: Severe Renal Impairment (RI), Group 2: End-stage renal disease (ESRD), Group 3: Healthy Participants
Fludrocortisone acetateAlso: HRTOral tablet	Drug	Group 1: Severe Renal Impairment (RI), Group 2: End-stage renal disease (ESRD), Group 3: Healthy Participants

Primary outcome

Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma.
Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma.
Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684
Time frame: At protocol specific time points pre-dose and up to 24 hours post-dose
Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma.
Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the Cmax of MK-5684 in plasma.
Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the Tmax of MK-5684 in plasma.
Apparent Terminal Half-Life (t½) of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the t1/2 of MK-5684 in plasma.
Apparent Clearance (CL/F) of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the CL/F of MK-5684 in plasma.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Blood samples will be collected to determine the Vz/F of MK-5684 in plasma.

5 secondary outcomes

Number of Participants who Experience an Adverse Event (AE)
Time frame: Up to ~21 days
Number of Participants who Discontinue Study Intervention Due to an AE
Time frame: Up to ~7 days
Dialysis Clearance (CLD) of MK5684 Based on Plasma
Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose
Concentration of Dialysate (CD) of MK-5684 Samples
Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose
Amount of drug (AD) of MK-5684 recovered from each dialysate collection
Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684 (time frame: At protocol specific time points pre-dose and up to 72 hours post-dose). The study lists 8 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 NCT06814132.

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 23 Oct 2025.