LNP023 for IgA Nephropathy
(APPLAUSE-IgAN Trial)
Recruiting at 212 trial locations
NP
NP
Overseen ByNovartis Pharmaceuticals
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.
Research Team
NP
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
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.
See 11 more
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.
See 3 more
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD