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Long-term Study of Iptacopan for C3 Glomerulopathy or IC-MPGN

This study is looking at the long-term effects of a medication called iptacopan (LNP023 capsules) for people with C3 Glomerulopathy (C3G) or Immune-complex-membranoproliferative Glomerulonephritis (IC-MPGN). These are rare kidney diseases. You can join this study if you have already completed a previous study with iptacopan. The researchers want to see how well iptacopan works over time and if it is safe. For people with C3G, success means reaching a specific kidney health goal. For those with IC-MPGN, it means a change in C3 deposits in the kidney. The study aims to enroll 225 participants and is an extension of earlier studies.

Study design
This is an open-label extension study, meaning everyone knows they are receiving iptacopan. It is designed to collect long-term data from participants who have already been in other iptacopan studies.
What's involved
You would continue taking iptacopan capsules. Participants are expected to stay in the study for a minimum of 60 months and a maximum of 84 months, with regular assessments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety events for a minimum of 60 months and a maximum of 84 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03955445

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

Recruiting
PHASE3Ages 12+InterventionalTreatment
Novartis Pharmaceuticals
~225 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:LNP023

At a glance

Recruiting sites
36 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint
Measured over 9-month visit
+4 more outcomes measured

Conditions

C3 Glomerulopathy
Immune-complex-membranoproliferative Glomerulonephritis

Explore related trials

C3 glomerulopathyImmune-complex-membranoproliferative Glomerulonephritis

Where it's being run

53 sites across 37 states
Germany5
France4
Spain4
São Paulo2
China2
Greece2
Israel2
Hokkaido2

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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 investigator and sponsor 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 screening, 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
History of HIV or any other immunodeficiency disease

What this trial measures

  • CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint9-month visit

    A participant meets the requirements of the composite renal endpoint if they satisfy the following criteria at the 9-month visit in CLNP023B12001B: (1) a stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to \<300 mg/g in UPCR and (3) either a ≥50% increase in C3 compared to baseline or an increase to ≥90 mg/dL (i.e., ≥ the lower limit of normal (LLN)). Initiation of treatment with eculizumab or any other complement pathway modifying agent automatically designates the participant as not meeting the endpoint.

  • CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score6 - to 9- month visit

    Change from baseline in the C3 Deposit Score (based on immunofluorescence microscopy) compared to baseline in the CLNP023X2202 study.

  • Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

    Number of participants with AEs of special interest will be collected to evaluate the long-term safety and tolerability of iptacopan in participants.

  • Number of participants with study drug discontinuation due to an AE (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302Participants 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 AE to evaluate the long-term safety and tolerability of iptacopan in participants.

  • Number of participants with abnormal clinically significant vital signs,ECGs, and safety laboratory measurements for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months

    Number of participants with abnormal clinically significant vital signs, ECGs, and safety laboratory measurements to evaluate the long-term safety and tolerability of iptacopan in participants.