Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT06814132
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria include, but are not limited to:
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):
* 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
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
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):
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06814132
Study Brief:
Protocol Section:
NCT06814132