PS-002 for IgA Nephropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called PS-002 to determine its safety and effectiveness for individuals with primary IgA nephropathy, a kidney disease caused by immune system damage. Researchers are testing various doses to identify the optimal one for future studies. This trial suits those diagnosed with primary IgA nephropathy who show signs of kidney problems despite existing treatments and do not have other major health issues. Participants will receive close monitoring for a year and may join a long-term follow-up study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that participants stop taking certain medications, such as immunosuppressive agents and oral budesonide, at least 90 days before starting the study drug. If you're on these medications, you'll need to stop them before joining the trial.
Is there any evidence suggesting that PS-002 is likely to be safe for humans?
Research has shown that PS-002 has been safe in animal studies. In pigs, this treatment increased activity in kidney cells without causing any safety problems, suggesting that PS-002 might be well-tolerated.
As this is the first time PS-002 is being tested in humans, researchers are still learning about its safety in people. The trial will monitor participants closely for a year to check for any side effects. This careful monitoring helps identify and address potential issues quickly.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for IgA nephropathy, which often include corticosteroids and immunosuppressants, PS-002 offers a novel approach by specifically targeting the underlying disease process. Researchers are excited about PS-002 because it uses a new mechanism of action that could potentially reduce kidney inflammation more effectively. Additionally, the treatment's dose escalation design allows for fine-tuning the optimal dose, which may enhance its safety and efficacy compared to current options. This innovation has the potential to better manage IgA nephropathy and improve patient outcomes.
What evidence suggests that PS-002 might be an effective treatment for IgA nephropathy?
Research has shown that PS-002 targets a part of the immune system that may cause IgA nephropathy, a kidney disease. In studies with mice, PS-002 improved kidney function and health, suggesting it might help treat IgA nephropathy in people. Although these results come from animal studies, they indicate that PS-002 could be a promising treatment for this kidney condition. Participants in this trial will receive different doses of PS-002 to evaluate its effectiveness and safety.12346
Are You a Good Fit for This Trial?
Adults with primary IgA nephropathy, a kidney disorder, who are at high risk of their disease getting worse despite current treatments. Specific details on eligibility criteria 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 PS-002 in a two-part study: Part 1 involves dose escalation, and Part 2 involves dose expansion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are invited to take part in a long-term follow-up study
What Are the Treatments Tested in This Trial?
Interventions
- PS-002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Purespring Therapeutics Limited
Lead Sponsor