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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
APPLAUSE-IgAN 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.Check my eligibility
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.See study design
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.
APPLAUSE-IgAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
APPLAUSE-IgAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2023 Phase 3 trial • 97 Patients • NCT0455891820%
COVID-19
17%
Breakthrough haemolysis
9%
Blood lactate dehydrogenase increased
9%
Pyrexia
9%
Sinusitis
9%
Nasopharyngitis
9%
Upper respiratory tract infection
6%
Diarrhoea
6%
Back pain
3%
Pseudomonal sepsis
3%
Vomiting
3%
Headache
3%
Abdominal pain
3%
Nausea
3%
Extravascular haemolysis
3%
Bilirubinuria
3%
Arthralgia
3%
Jaundice
3%
Sepsis
3%
Intervertebral discitis
3%
Influenza A virus test positive
3%
Arthritis bacterial
3%
Acute kidney injury
3%
Urinary tract infection
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)
APPLAUSE-IgAN 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
2,855 Previous Clinical Trials
4,196,832 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have IgA nephropathy linked to another health condition.I am 18 or older with IgA nephropathy confirmed by biopsy and kidney function test.You have a history of frequent serious infections caused by certain types of bacteria like meningococcus and pneumococcus.My kidney function is low, but a biopsy showed less than 50% damage.I have IgA nephropathy with high protein levels in my urine.My kidney function is low, and I've had a qualifying biopsy.My kidney function is low, but I've had a qualifying biopsy.I have not had any serious infections like COVID-19 in the last 14 days.Your blood pressure is too high when checked at the doctor's office.If there is no record of a previous tissue sample, a new one may be taken during the initial assessment. Additionally, the participant's kidney function will be calculated using a specific formula based on their ethnic group and local guidelines.I have been vaccinated against Neisseria meningitidis or will be before starting the study treatment.I haven't taken strong immune system affecting drugs or steroids recently.I have been vaccinated against meningitis and pneumonia or will be before treatment starts.I've been on a stable dose of heart or blood pressure medication for about 3 months.My kidney function is low, but I had a biopsy showing less than 50% damage in the last 2 years.I have previously taken iptacopan or was in a trial for it.I have been vaccinated against Haemophilus influenzae or will be 2 weeks before starting the study drug.My kidney function is good and I had a biopsy in the last 5 years.My kidney function is good and I've had a biopsy in the last 5 years.I have IgA nephropathy with protein levels in my urine above the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: LNP023 200mg b.i.d
- Group 2: Placebo to LNP023 200mg b.i.d
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ideal sample size for this research?
"That is accurate. The clinical trial was originally advertised on January 25th, 2021 and was last updated on November 7th, 2022. The study is hoping to enroll 450 patients from 42 different sites."
Answered by AI
Are there any observed side effects of LNP023?
"LNP023 has been given a safety score of 3 by our team at Power. This is because LNP023 is in Phase 3 trials, meaning that there is both efficacy data and multiple rounds of safety data available."
Answered by AI
Are there different hospitals conducting this research in Canada?
"This research is currently being conducted at 42 different locations, which include El Paso, Rochester, and Marshfield. To minimize potential participant burden, it is recommended to choose a location nearest to you."
Answered by AI
Are there any other instances where LNP023 has been tested in a clinical setting?
"LNP023 was first studied in 2019 at Novartis Investigative Site. Since then, there have been 18270 completed clinical trials. There are 10 active studies as of now, with a few of these trials taking place in El Paso, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Alberta
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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