Praliciguat for Focal Segmental Glomerulosclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests praliciguat, a new treatment for focal segmental glomerulosclerosis (FSGS), a kidney disease that can lead to kidney failure. The study aims to determine if praliciguat is safe and effective for this condition. Participants will receive either praliciguat or a placebo for 24 weeks, followed by praliciguat for another 24 weeks. Eligible participants must have an FSGS diagnosis confirmed by a kidney biopsy and currently take medication for high blood pressure. As a Phase 2 trial, this research measures praliciguat's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on the highest dose of ACE inhibitors or ARBs that you can tolerate. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that praliciguat is likely to be safe for humans?
Research shows that praliciguat is being tested for safety and effectiveness in treating focal segmental glomerulosclerosis (FSGS), a rare kidney disease. Earlier studies found no major safety concerns with praliciguat, suggesting it might be well-tolerated.
The trial has now reached a stage involving more participants to better assess the treatment's safety. Although no serious side effects have been reported so far, side effects can vary among individuals. Participants will take the drug over a period of time, allowing researchers to gather more safety data.
Prospective participants should discuss any concerns with the trial team or their doctor.12345Why do researchers think this study treatment might be promising for FSGS?
Praliciguat is unique because it targets a different pathway than most current treatments for focal segmental glomerulosclerosis (FSGS), which generally focus on managing symptoms with steroids or immunosuppressants. Praliciguat works by enhancing the nitric oxide-cyclic GMP pathway, which can improve kidney function by reducing inflammation and fibrosis. Researchers are excited about this treatment because it offers a novel mechanism of action that holds the potential for better outcomes and fewer side effects compared to traditional therapies.
What evidence suggests that praliciguat might be an effective treatment for FSGS?
Research has shown that praliciguat might help treat focal segmental glomerulosclerosis (FSGS). In this trial, participants will receive either praliciguat or a placebo. Praliciguat opens blood vessels, which can lower blood pressure. Early results suggest it could also improve kidney function, crucial for people with FSGS. Past studies found praliciguat generally safe, with few side effects. While it primarily affects blood pressure, researchers believe it might also benefit kidney health. However, more research is needed to confirm its effectiveness for FSGS.12346
Are You a Good Fit for This Trial?
Adults with biopsy-confirmed FSGS (a kidney disease causing scarring and protein loss in urine) can join this trial. Participants will be randomly assigned to receive either the test drug praliciguat or a placebo for 24 weeks, followed by an open-label extension where all get praliciguat.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive praliciguat or placebo for an initial 24-week double-blind period
Open-label extension
All participants receive praliciguat in an open-label extension for an additional 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Praliciguat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Akebia Therapeutics
Lead Sponsor