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
3 other identifiers
interventional
225
17 countries
50
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2019
Longer than P75 for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
October 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2036
April 14, 2026
April 1, 2026
16.7 years
May 3, 2019
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint
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.
9-month visit
CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score
Change from baseline in the C3 Deposit Score (based on immunofluorescence microscopy) compared to baseline in the CLNP023X2202 study.
6 - to 9- month visit
Number of AEs of special interest for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302
Number of participants with AEs of special interest will be collected to evaluate the long-term safety and tolerability of iptacopan in participants.
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 AE (or any safety issue) for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302
Number of participants with study drug discontinuation due to an AE to evaluate the long-term safety and tolerability of iptacopan in participants.
Participants 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 for participants from CLNP023X2202, CLNP023B12301 and CLNP023B12302
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.
Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
Secondary Outcomes (12)
CLNP023X2202: Number of participants who achieve the 2-component composite renal endpoint
9-month visit
CLNP023X2202: Change from baseline in log-transformed urine protein/creatinine ratio (UPCR)
Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
CLNP023X2202: Change from baseline in log-transformed urine albumin/creatinine ratio (UACR)
Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
CLNP023X2202: Change from baseline in serum creatinine concentration
Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
CLNP023X2202: Change from baseline in estimated glomerular filtration rate (eGFR)
Participants are expected to continue on study for a minimum of 60 months and a maximum of 84 months
- +7 more secondary outcomes
Study Arms (6)
Cohort A: participants with native kidneys from CLNP023X2202
EXPERIMENTALC3G participants from study CLNP023X2202 with native kidneys receiving iptacopan capsules 200 mg b.i.d
Cohort B: participants with transplanted kidneys and recurrent C3G from CLNP023X2202
EXPERIMENTALC3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving iptacopan capsules 200 mg b.i.d
Cohort C: Participants with native C3G randomized to placebo in CLNP023B12301
EXPERIMENTALNative C3G Participants (adults and adolescents) from CLNP023B12301 study who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
Cohort D: particpants with native C3G randomised to iptacopan in CLNP023B12301
EXPERIMENTALNative C3G participants (adults and adolescents) from study CLNP023B12301 who were randomized to iptacopan in the core study. Receiving iptacopan capsules 200mg b.i.d
Cohort E: participants with IC-MPGN randomized to placebo in CLNP023B12302
EXPERIMENTALIC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to placebo in the core study receiving iptacopan capsules 200mg b.i.d
Cohort F: participants with IC-MPGN randomized to ipatocan in CLNP023B12302
EXPERIMENTALIC-MPGN participants (adults and adolescents) from study CLNP023B12302 who were randomized to iptacopan in the core study receiving iptacopan capsules 200mg b.i.d
Interventions
LNP023 capsules
Eligibility Criteria
You may qualify if:
- \- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Georgia Nephrology Research Inst
Lawrenceville, Georgia, 30046, United States
University of Iowa Health Care
Iowa City, Iowa, 52242-1091, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Col Uni Med Center New York Presby
New York, New York, 10032, United States
Novartis Investigative Site
CABA, Buenos Aires, C1425AGC, Argentina
Novartis Investigative Site
Buenos Aires, W3400ABH, Argentina
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Novartis Investigative Site
Recife, Pernambuco, 50740-900, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Novartis Investigative Site
Botucatu, São Paulo, 3880-1001, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 04038-002, Brazil
Novartis Investigative Site
Salvador, 40323-010, Brazil
Novartis Investigative Site
Toronto, Ontario, M5G 2C4, Canada
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Shanghai, 200040, China
Novartis Investigative Site
Prague, 128 08, Czechia
Novartis Investigative Site
Montpellier, 34295, France
Novartis Investigative Site
Paris, 75015, France
Novartis Investigative Site
Toulouse, 31054, France
Novartis Investigative Site
Erlangen, 91054, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Heraklion Crete., 715 00, Greece
Novartis Investigative Site
Thessaloniki, 546 42, Greece
Novartis Investigative Site
Petah Tikva, 4920235, Israel
Novartis Investigative Site
Petah Tikva, 4941492, Israel
Novartis Investigative Site
Ranica, BG, 24020, Italy
Novartis Investigative Site
Roma, 165, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, 0788510, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 0608543, Japan
Novartis Investigative Site
Takatsuki, Osaka, 5691192, Japan
Novartis Investigative Site
Ohtsu, Shiga, 5202192, Japan
Novartis Investigative Site
Hachiōji, Tokyo, 193-0998, Japan
Novartis Investigative Site
Niigata, 9518520, Japan
Novartis Investigative Site
Leiden, South Holland, 2333 ZA, Netherlands
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
Barcelona, 08035, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Seville, 41009, Spain
Novartis Investigative Site
Bern, 3010, Switzerland
Novartis Investigative Site
Köseköy, Kocaeli, 41380, Turkey (Türkiye)
Novartis Investigative Site
Kayseri, Melikgazi, 38039, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Yenimahalle, 06500, Turkey (Türkiye)
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Novartis Investigative Site
Cardiff, CF14 4XW, United Kingdom
Novartis Investigative Site
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 20, 2019
Study Start
October 3, 2019
Primary Completion (Estimated)
May 30, 2036
Study Completion (Estimated)
May 30, 2036
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.