Sparsentan for IgA Nephropathy
(PROTECT Trial)

Recruiting in Palo Alto (17 mi)

+155 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Travere Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

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).

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

I am willing to change my blood pressure medications if needed.

Did not permanently discontinue study medication during the double-blind period

I have been on a stable dose of ACEI or ARB for at least 12 weeks.

+7 more

Exclusion Criteria

I am currently pregnant or breastfeeding.

I do not have jaundice, hepatitis, or liver disease, and my liver tests are normal.

I couldn't start or had to stop RAAS inhibitors between Week 110 and 114.

+25 more

Participant Groups

The trial is testing the long-term kidney protection of Sparsentan compared to an angiotensin receptor blocker in patients with IgA Nephropathy over approximately two years. Participants will either continue with their current treatment or switch to Sparsentan.

4Treatment groups

Experimental Treatment

Active Control

Group I: sparsentan (Sub Study)Experimental Treatment1 Intervention

OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.

Group II: sparsentanExperimental Treatment1 Intervention

Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.

Group III: dapagliflozin + sparsentan (Sub study)Experimental Treatment2 Interventions

OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.

Group IV: irbesartanActive Control1 Intervention

Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.