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Complement Inhibitor

LNP023 for IgA Nephropathy (APPLAUSE-IgAN Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy
Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline.
Must not have
Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration
Patients previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Pivotal Trial

Summary

This trial will test whether LNP023 is better than placebo at reducing proteinuria and slowing renal disease progression in people with primary IgA nephropathy.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects aren't listed here, but generally, study drugs like iptacopan could cause issues such as headaches, nausea, or allergic reactions. The exact side effects would be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with IgA nephropathy confirmed by biopsy and kidney function test.
Select...
I have IgA nephropathy with high protein levels in my urine.
Select...
My kidney function is low, but I've had a qualifying biopsy.
Select...
I have IgA nephropathy with protein levels in my urine above the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had any serious infections like COVID-19 in the last 14 days.
Select...
I haven't taken strong immune system affecting drugs or steroids recently.
Select...
I have previously taken iptacopan or was in a trial for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized total estimated Glomerular Filtration Rate (eGFR) slope over 24 months).
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months
Secondary study objectives
Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months
Change from baseline in estimated glomerular filtration rate at 9 months
Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire
+5 more

Side effects data

From 2023 Phase 3 trial • 97 Patients • NCT04558918
20%
COVID-19
17%
Breakthrough haemolysis
9%
Pyrexia
9%
Nasopharyngitis
9%
Sinusitis
9%
Upper respiratory tract infection
9%
Blood lactate dehydrogenase increased
6%
Diarrhoea
6%
Back pain
3%
Sepsis
3%
Extravascular haemolysis
3%
Jaundice
3%
Arthritis bacterial
3%
Intervertebral discitis
3%
Pseudomonal sepsis
3%
Influenza A virus test positive
3%
Acute kidney injury
3%
Bilirubinuria
3%
Abdominal pain
3%
Nausea
3%
Vomiting
3%
Urinary tract infection
3%
Arthralgia
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anti-C5 Antibody (Randomized Treatment Period)
Any LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LNP023
2019
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,158 Total Patients Enrolled

Media Library

LNP023 (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04578834 — Phase 3
Immunoglobulin A Nephropathy Research Study Groups: LNP023 200mg b.i.d, Placebo to LNP023 200mg b.i.d
Immunoglobulin A Nephropathy Clinical Trial 2023: LNP023 Highlights & Side Effects. Trial Name: NCT04578834 — Phase 3
LNP023 (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04578834 — Phase 3
~93 spots leftby Oct 2025
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