Phase
Condition
Kidney Failure (Pediatric)
Nephropathy
Kidney Disease
Treatment
Fludrocortisone acetate
MK-5684
Prednisone
Clinical Study ID
Ages 18-85 Male Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida 32809
United StatesActive - Recruiting
Research by Design ( Site 0001)
Chicago, Illinois 60643
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.