Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
NCT ID: NCT04817618
Last Updated: 2025-03-04
Study Results
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Basic Information
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RECRUITING
PHASE3
98 participants
INTERVENTIONAL
2021-07-28
2026-07-04
Brief Summary
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The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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iptacopan 200mg
iptacopan 200 mg b.i.d.
iptacopan
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Placebo to iptacopan 200mg
Placebo to iptacopan 200mg b.i.d.
Placebo
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Interventions
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Placebo
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
iptacopan
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
* Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
* UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
* Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.
* If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
Exclusion Criteria
* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
* Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
* Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
* The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
* A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
* The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
* The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.
* Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.
12 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Childrens Hospital Colorado
Aurora, Colorado, United States
Nicklaus Childrens Hospital
Miami, Florida, United States
Georgia Nephrology Research Inst
Lawrenceville, Georgia, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Albany Medical Center
Albany, New York, United States
Col Uni Med Center New York Presby
New York, New York, United States
Baylor Scott and White Research
Temple, Texas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Edegem, , Belgium
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Leuven, , Belgium
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Belo Horizonte, Minas Gerais, Brazil
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Pernambuco, Recife, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Joinville, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, , Brazil
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Guangzhou, Guangdong, China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Wuhan, , China
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Prague, , Czechia
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Aachen, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Mainz, , Germany
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Athens, , Greece
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Heraklion Crete, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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New Delhi, National Capital Territory of Delhi, India
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Hyderabad, Telangana, India
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Lucknow, Uttar Pradesh, India
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Dehradun, Uttarakhand, India
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New Delhi, , India
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Petah Tikva, , Israel
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Petah Tikva, , Israel
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Ranica, BG, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Nagoya, Aichi-ken, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Takatsuki, Osaka, Japan
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Ohtsu, Shiga, Japan
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Niigata, , Japan
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Leiden, South Holland, Netherlands
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Nijmegen, , Netherlands
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Port de Sagunt, Valencia, Spain
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Madrid, , Spain
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Bern, , Switzerland
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Lausanne, , Switzerland
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Istanbul, TUR, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Talas Kayseri, , Turkey (Türkiye)
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Glasgow, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Role: primary
Nikki Gerot
Role: primary
References
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Kavanagh D, Bomback AS, Vivarelli M, Nester CM, Remuzzi G, Zhao MH, Wong EKS, Wang Y, Krishnan I, Schuhmann I, Trapani AJ, Webb NJA, Meier M, Israni RK, Smith RJH; APPEAR-C3G investigators. Oral iptacopan therapy in patients with C3 glomerulopathy: a randomised, double-blind, parallel group, multicentre, placebo-controlled, phase 3 study. Lancet. 2025 Oct 11;406(10512):1587-1598. doi: 10.1016/S0140-6736(25)01148-1. Epub 2025 Sep 25.
Other Identifiers
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2020-004589-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLNP023B12301
Identifier Type: -
Identifier Source: org_study_id
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