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Complement Inhibitor
Iptacopan for IgA Nephropathy
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening visit, months 1, 3, 6, 9, 12 and every 6 months thereafter
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of a new drug, iptacopan, to treat IgA nephropathy over a long period of time.
Who is the study for?
This trial is for people with a kidney condition called primary IgA nephropathy who finished earlier trials (CLNP023X2203 or CLNP023A2301). They should be up-to-date on certain vaccinations and judged by their doctor to benefit from the drug iptacopan. Participants must also follow specific guidelines for kidney care and have a minimum eGFR of 20 ml/min/1.73m2.Check my eligibility
What is being tested?
The study tests the long-term safety and effects of iptacopan, an investigational drug, in patients with IgA nephropathy. It's open-label, meaning everyone knows they're getting iptacopan, and it continues until the drug is commercially available.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system suppression since iptacopan affects blood components involved in inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking ACE inhibitors or ARBs as part of my treatment plan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening visit, months 1, 3, 6, 9, 12 and every 6 months thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening visit, months 1, 3, 6, 9, 12 and every 6 months thereafter
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and percentage of participants with abnormalities in ECG
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Number and percentage of participants with abnormalities in vital signs
+3 moreSecondary outcome measures
Annualized total eGFR slope
Change from baseline in eGFR
Log transformed ratio to baseline in UPCR, UACR
Side 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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: LNP023Experimental Treatment1 Intervention
All participants are receiving 200 mg b.i.d
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
2,860 Previous Clinical Trials
4,197,809 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe problems urinating or other urinary tract issues not related to IgAN.I am taking ACE inhibitors or ARBs as part of my treatment plan.I haven't taken strong immune system affecting drugs recently.I can't take certain blood pressure medicines due to allergies or intolerance.Your kidney function, measured by eGFR, is at least 20 ml/min/1.73m2.I am not using any experimental drugs or haven't used any in the last 30 days or 5 half-lives, whichever is longer.My doctor thinks the treatment iptacopan could help me.My vaccinations for meningitis, pneumonia, and Haemophilus influenzae are current.You have a history of getting serious infections from bacteria like meningococcus and pneumococcus more than once.You have had an acute kidney injury within the past 4 weeks.My kidney function has declined by 50% in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: LNP023
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Has this clinical trial ever been attempted before?
"Presently, 7 extant studies of LNP023 are ongoing across 42 countries and 172 cities. In 2019, Novartis Pharmaceuticals conducted the first trial which encompassed 95 participants; this research completed Phase 2 drug approval with success. Thereafter, 8 additional trials have been successfully concluded."
Answered by AI
Are new subjects being accepted into this clinical experiment currently?
"Affirmative. Clinicaltrials.gov attests to this clinical trial's current recruitment status, which began on September 20th 2021 and was last modified on May 15th 2023. This medical experiment needs 410 volunteers from 41 distinct sites."
Answered by AI
What danger, if any, does LNP023 pose to participants?
"Our team at Power graded the safety of LNP023 with a 3 out of 3, based on existing efficacy data and multiple protective tests conducted for this Phase 3 trial."
Answered by AI
How many research facilities are currently conducting this experiment?
"Currently, 41 hospitals and medical centres are running this trial. Participants can select the nearest clinic to them from locations such as Kansas City, Guangzhou, Beijing and other cities. This is beneficial for lowering transport costs associated with taking part in the experiment."
Answered by AI
How many participants are enlisted in the current experiment?
"Affirmative. The clinicaltrial.gov website reports that the trial is currently recruiting participants, with 410 individuals required from 41 sites across the nation. This research was initially posted on September 20th 2021 and most recently updated in May 15th of 2023."
Answered by AI
Who else is applying?
What site did they apply to?
Novartis Investigative Site
AZ Kidney Dise and Hypertension Ctr
What portion of applicants met pre-screening criteria?
Did not meet criteria
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