Trial Profile
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 06 Apr 2024
Price :
$35
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At a glance
- Drugs Sparsentan (Primary) ; Irbesartan
- Indications IgA nephropathy
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms PROTECT
- Sponsors Travere Therapeutics
- 03 Apr 2024 According to a Travere Therapeutics media release, subgroup analyses of 2-Year results and early clinical experience from the PROTECT open-label extension will be presented at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.
- 19 Mar 2024 According to a Travere Therapeutics media release, based on results form this trial the company announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for conversion of the existing U.S. accelerated approval of FILSPARI (sparsentan) in IgA nephropathy (IgAN) to full approval.
- 23 Feb 2024 According to a Travere Therapeutics media release, the positive CHMP opinion is based on results from the pivotal Phase 3 PROTECT Study of sparsentan in IgAN