LNP023 for IgA Nephropathy
(APPLAUSE-IgAN Trial)

Recruiting in Palo Alto (17 mi)

+212 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Eligibility Criteria

Adults with biopsy-confirmed IgA nephropathy, a kidney disease, and certain levels of protein in their urine can join. They must have been on stable doses of specific blood pressure medicines for about 90 days. Vaccinations against certain infections are required before starting the trial.

Inclusion Criteria

I am 18 or older with IgA nephropathy confirmed by biopsy and kidney function test.

My kidney function is low, but a biopsy showed less than 50% damage.

I have IgA nephropathy with high protein levels in my urine.

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Exclusion Criteria

I have IgA nephropathy linked to another health condition.

You have a history of frequent serious infections caused by certain types of bacteria like meningococcus and pneumococcus.

I have not had any serious infections like COVID-19 in the last 14 days.

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Treatment Details

Interventions

LNP023 (Complement Inhibitor)

Trial OverviewThe trial is testing if LNP023 (iptacopan) is better than a placebo at reducing proteinuria and slowing down kidney disease when taken alongside standard treatments. Participants will be randomly assigned to either the drug or placebo group without knowing which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LNP023 200mg b.i.dExperimental Treatment1 Intervention

Group II: Placebo to LNP023 200mg b.i.dPlacebo Group1 Intervention

LNP023 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as FABHALTA for: