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)

Last updated: June 3, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Kidney Failure (Pediatric)

Nephropathy

Kidney Disease

Treatment

Fludrocortisone acetate

MK-5684

Prednisone

Clinical Study ID

NCT06814132
5684-010
MK-5684-010
CA43216
  • Ages 18-85
  • Male
  • Accepts Healthy Volunteers

Study 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 healthy people.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion criteria include, but are not limited to:

All Participants

  • Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day orequivalent) 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 glomerularfiltration rate (eGFR) using the 2021 Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation

Participants with end-stage renal disease (ESRD) (Group 2):

  • Has ESRD maintained on stable outpatient regimen of intermittent high-fluxhemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysissession, using a complication free well-maintained arteriovenous fistula orarteriovenous graft, for at least 3 months prior to first dosing and is expected andplanning to continue HD during the study and at least up to the follow-up visit

Healthy Control Participants (Group 3):

  • Has normal renal function

Exclusion

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

All Participants:

  • Has a history or presence of any of the following: Adrenal insufficiency; Hepaticimpairment; Clinically significant hypotension; cardiac arrhythmia; cardiacconduction abnormalities or recurrent unexplained syncopal events; Second- orthird-degree atrioventricular (AV) heart block (except in participants with afunctional artificial pacemaker); Clinically significant sick sinus syndrome; Anysystemic fungal infection; Hypothyroidism; Chronic infection

  • Has a first-degree relative with multiple unexplained syncopal events, unexplainedcardiac arrest, or sudden cardiac death, or has a known family history of aninherited 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):

  • 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

Study Design

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: Fludrocortisone acetate
Phase: 1
Study Start date:
April 07, 2025
Estimated Completion Date:
September 05, 2025

Connect with a study center

  • Orlando Clinical Research Center ( Site 0002)

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Research by Design ( Site 0001)

    Chicago, Illinois 60643
    United States

    Active - Recruiting

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