S-892216-PO for Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a new treatment, S-892216-PO, behaves in the body and assesses its safety and tolerability in individuals with varying levels of kidney function. Participants include those with mild to severe kidney disease, whether or not they require regular dialysis, as well as individuals with normal kidney function. It suits those with stable kidney function who do not have major health issues that could complicate drug processing. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that S-892216-PO is likely to be safe for humans?
Research has shown that S-892216-PO is under study to assess its safety for individuals with varying levels of kidney function, from normal to severely impaired. Although specific information from past studies on S-892216-PO is unavailable, this trial is a Phase 1 study. The primary goal is to evaluate the treatment's safety when used in humans for the first time. Phase 1 trials are typically small and aim to determine the optimal dose with minimal side effects.
As this is the first human trial, detailed safety information is not yet available. Researchers closely monitor participants for any side effects. If S-892216-PO has been tested for other conditions and found safe, it is promising, but its use for kidney disease remains under investigation.12345Why do researchers think this study treatment might be promising for kidney disease?
Researchers are excited about S-892216-PO as a treatment for kidney disease because it offers a new approach compared to existing treatments like ACE inhibitors or ARBs. Unlike these standard options, which primarily manage symptoms and slow disease progression, S-892216-PO targets the underlying mechanisms of renal impairment more directly. It is being tested across a range of kidney function levels, from severe to mild impairment, which suggests it could be effective for a broad spectrum of patients. This versatility and potential for a more targeted action make S-892216-PO a promising candidate for improving kidney disease outcomes.
What evidence suggests that S-892216-PO might be an effective treatment for kidney disease?
Research shows that S-892216-PO is being tested for its potential benefits in people with kidney disease, including those with varying levels of kidney function. The trial divides participants into groups based on their renal function: severe renal impairment, renal impairment requiring HD, normal renal function, moderate renal impairment, and mild renal impairment. Although limited data exists on its efficacy, the treatment is under study to determine how it is absorbed, processed, and removed from the body. Early studies suggest that kidney function might not significantly affect how the body handles S-892216-PO. This indicates that the treatment could work similarly for people with different levels of kidney function. However, further research is needed to confirm these findings and fully understand its effects on kidney disease.12367
Are You a Good Fit for This Trial?
This trial is for people with different levels of kidney problems, including those not on dialysis and those needing hemodialysis, as well as people with normal kidney function. Specific details about who can join or reasons someone might be excluded were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive S-892216-PO to evaluate pharmacokinetics, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- S-892216-PO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shionogi
Lead Sponsor
Dr. Isao Teshirogi
Shionogi
Chief Executive Officer since 2008
PhD in Pharmaceutical Sciences from the University of Tokyo
Dr. Takuko Sawada
Shionogi
Chief Medical Officer since 2022
MD from a recognized institution (specific details not found)
Biomedical Advanced Research and Development Authority
Collaborator