Comparing 6 approaches for C3 glomerulopathy
Official title: Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis
- Phase 3
- 6 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
LNP023
LNP023 capsules
Canadian Sites (1)
1 listed, none recruiting
- Not currently recruiting
Novartis Investigative Site
Toronto, Ontario
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
Exclusion
- −History of HIV or any other immunodeficiency disease
- −Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and sponsorSponsorThe organisation responsible for the study overall.Read more → is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study
- −Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
- −History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Groups A, B, C, D, E and F receive LNP023.
Registry label: A: Cohort A: participants with native kidneys from CLNP023X2202 · B: Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202 · C: Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301 · D: Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301 · E: Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302 · F: Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 12 years to 100 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 225 people.
The study is currently expected to finish around May 2036.
The main measurement is taken over: 9-month visit.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
CLNP023X2202 CohortCohortA group of participants sharing a characteristic, followed together.Read more → A-native C3G: Number of participants who achieve the composite renal endpointEndpointThe specific thing a study measures to answer its question.Read more → — measured over 9-month visit.
CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in the C3 Deposit Score — measured over 6 - to 9- month visit.
Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 — measured over Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months.
Number of participants with study drug discontinuation due to an AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302 — measured over Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03955445 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LNP023Drug
LNP023 capsules
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 100 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 100 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 9-month visit.
The study as a whole is currently expected to finish around 2036-05-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 225 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Toronto, Ontario, Canada; Minneapolis, Minnesota, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
Other Sites (2)
University of Minnesota
Minneapolis, Minnesota, United States
Col Uni Med Center New York Presby
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.