Sparsentan for IgA Nephropathy
(PROTECT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to be on a stable dose of ACEI (angiotensin-converting enzyme inhibitor) and/or ARB (angiotensin receptor blocker) therapy for at least 12 weeks before screening. You must be willing to change these medications if needed, but the protocol does not specify stopping other current medications.
What data supports the effectiveness of the drug Sparsentan for IgA Nephropathy?
Sparsentan has been shown to significantly reduce proteinuria (excess protein in urine, a sign of kidney damage) compared to irbesartan in patients with IgA nephropathy, according to a phase 3 clinical trial. It received accelerated approval in the USA for reducing proteinuria in adults at risk of rapid disease progression.12345
Is Sparsentan safe for humans?
Sparsentan has been studied in clinical trials for conditions like IgA nephropathy and focal segmental glomerulosclerosis, showing a favorable safety profile compared to irbesartan, another similar medication. It is a non-immunosuppressive treatment, meaning it doesn't weaken the immune system, and has been approved in the USA for certain kidney conditions.12456
How is the drug Sparsentan different from other treatments for IgA nephropathy?
Sparsentan is unique because it is a dual endothelin angiotensin receptor antagonist, meaning it blocks two pathways that can lead to kidney damage, and it is not an immunosuppressant, unlike some other treatments. It has shown significant reduction in proteinuria (excess protein in urine) compared to irbesartan, a standard angiotensin II receptor blocker, in clinical trials.12456
What is the purpose of this trial?
To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).
Research Team
Radko Komers, MD, PhD
Principal Investigator
Travere Therapeutics, Inc.
Eligibility Criteria
Adults with IgA Nephropathy (kidney disease) who've completed a previous study phase, have stable blood pressure and kidney function, are on certain blood pressure meds, and agree to contraception can join. Excluded if they're pregnant/breastfeeding, drug/alcohol disorder, severe liver issues, high potassium levels or taking disallowed medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sparsentan or irbesartan in a double-blind manner, with dose adjustments after 2 weeks, continuing treatment to Week 110
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue treatment with sparsentan for up to 156 weeks, with an optional sub-study involving dapagliflozin
Treatment Details
Interventions
- Irbesartan
- Sparsentan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Travere Therapeutics, Inc.
Lead Sponsor