Actively Recruiting
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
Led by Shionogi · Updated on 2025-10-30
40
Participants Needed
4
Research Sites
33 weeks
Total Duration
On this page
Sponsors
S
Shionogi
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.
CONDITIONS
Official Title
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Considered healthy or medically stable by medical evaluation including history, physical exam, lab tests, vital signs, and ECG
- Participants with mild, moderate, or severe renal impairment not on hemodialysis based on eGFR and body surface area
- Participants receiving stable hemodialysis at least 3 times a week for 6 months prior to screening
- Participants with normal renal function with clinical lab tests within normal range or not clinically significant abnormality
- Renal function must be normal (eGFR ≥90 mL/min) for normal renal function group
You will not qualify if you...
- Life expectancy less than or equal to 3 months
- Presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders that affect drug absorption, metabolism, or elimination or pose risk
- For normal renal function group: history or presence of renal disorders affecting drug processing or data interpretation
- For any renal impairment group: clinically significant lab values outside protocol limits during screening
- For mild to severe renal impairment not on hemodialysis: current or anticipated need for hemodialysis during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Orlando Clicinal Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
2
Global Clinical Professionals (GCP) LLC
St. Petersburg, Florida, United States, 33705
Actively Recruiting
3
Genesis Clinical Research
Tampa, Florida, United States, 33603
Actively Recruiting
4
Alliance for Multispecialty Research (AMR)-Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
S
Shionogi Clinical Trials Administrator Clinical Support Help Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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