Actively Recruiting
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Led by Novartis Pharmaceuticals · Updated on 2026-04-29
98
Participants Needed
87
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. 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.
CONDITIONS
Official Title
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants age 6 12 and 4 60 years at screening.
- Diagnosis of C3G confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
- Stable use of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximally recommended or tolerated dose for at least 90 days before randomization.
- Stable doses of other antiproteinuric medications including mycophenolic acid, corticosteroids, and mineralocorticoid receptor antagonists for at least 90 days prior to randomization.
- Reduced serum C3 level below 0.85 times the lower limit of normal at screening.
- Urine protein-to-creatinine ratio (UPCR) 6 1.0 g/g from first morning urine sample at Day -75 and Day -15.
- Estimated or measured glomerular filtration rate (eGFR or mGFR) 6 30 ml/min/1.73m2 at screening and Day -15.
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to starting study treatment.
- Vaccination against Haemophilus influenzae if not previously vaccinated or if booster is needed, at least 2 weeks before first treatment or with prophylactic antibiotics if treatment starts earlier.
You will not qualify if you...
- History of any cell or organ transplantation including kidney transplantation.
- Rapidly progressive crescentic glomerulonephritis with 50% decline in eGFR within 3 months and biopsy showing crescents in at least 50% of glomeruli.
- Renal biopsy showing more than 50% interstitial fibrosis/tubular atrophy.
- Monoclonal gammopathy of undetermined significance confirmed by serum free light chains or local investigations.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to treatment.
- Fever of 386C (100.46F) or higher within 7 days prior to treatment.
- History of recurrent invasive infections caused by encapsulated organisms like Neisseria meningitidis and Streptococcus pneumoniae.
- Use of complement inhibitors (Factor B, Factor D, C3 inhibitors, anti-C5 antibodies, C5a receptor antagonists) within 6 months before screening.
- Use of immunosuppressants (except mycophenolic acids), cyclophosphamide, or systemic corticosteroids over 7.5 mg/day within 90 days before study drug.
- Acute post-infectious glomerulonephritis at screening as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 87 locations
1
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Nicklaus Childrens Hospital
Miami, Florida, United States, 33155
Actively Recruiting
3
Georgia Nephrology Research Inst
Lawrenceville, Georgia, United States, 30046
Active, Not Recruiting
4
IN University School of Med
Indianapolis, Indiana, United States, 46202-5111
Withdrawn
5
University of Iowa Health Care
Iowa City, Iowa, United States, 52242-1091
Actively Recruiting
6
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
7
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Withdrawn
8
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States, 02115
Withdrawn
9
Hackensack Uni Medical Center
Hackensack, New Jersey, United States, 07601
Withdrawn
10
Albany Medical Center
Albany, New York, United States, 12208
Withdrawn
11
Col Uni Med Center New York Presby
New York, New York, United States, 10032
Completed
12
Baylor Scott and White Research
Temple, Texas, United States, 76502
Withdrawn
13
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
14
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina, 5000
Withdrawn
15
Novartis Investigative Site
Buenos Aires, Argentina, W3400ABH
Completed
16
Novartis Investigative Site
CABA, Argentina, C1181ACH
Withdrawn
17
Novartis Investigative Site
Edegem, Belgium, 2650
Withdrawn
18
Novartis Investigative Site
Leuven, Belgium, 3000
Withdrawn
19
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Actively Recruiting
20
Novartis Investigative Site
Recife, Pernambuco, Brazil, 50740-900
Actively Recruiting
21
Novartis Investigative Site
Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
Actively Recruiting
22
Novartis Investigative Site
Joinville, Santa Catarina, Brazil, 893227-680
Withdrawn
23
Novartis Investigative Site
Santo André, São Paulo, Brazil, 09090-790
Withdrawn
24
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04038-002
Actively Recruiting
25
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
Withdrawn
26
Novartis Investigative Site
Salvador, Brazil, 40323-010
Actively Recruiting
27
Novartis Investigative Site
London, Ontario, Canada, N6A 5W9
Completed
28
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2C4
Completed
29
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1C5
Withdrawn
30
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
Active, Not Recruiting
31
Novartis Investigative Site
Wuhan, Hubei, China, 430022
Withdrawn
32
Novartis Investigative Site
Beijing, China, 100034
Active, Not Recruiting
33
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
34
Novartis Investigative Site
Shanghai, China, 200040
Active, Not Recruiting
35
Novartis Investigative Site
Prague, Czechia, 128 08
Completed
36
Novartis Investigative Site
Lille, France, 59037
Completed
37
Novartis Investigative Site
Marseille, France, 13005
Withdrawn
38
Novartis Investigative Site
Montpellier, France, 34295
Withdrawn
39
Novartis Investigative Site
Paris, France, 75015
Completed
40
Novartis Investigative Site
Paris, France, 75019
Withdrawn
41
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Active, Not Recruiting
42
Novartis Investigative Site
Aachen, Germany, 52074
Withdrawn
43
Novartis Investigative Site
Erlangen, Germany, 91054
Completed
44
Novartis Investigative Site
Essen, Germany, 45147
Completed
45
Novartis Investigative Site
Hamburg, Germany, 20246
Completed
46
Novartis Investigative Site
Hanover, Germany, 30625
Withdrawn
47
Novartis Investigative Site
Heidelberg, Germany, 69120
Active, Not Recruiting
48
Novartis Investigative Site
Mainz, Germany, 55131
Completed
49
Novartis Investigative Site
Athens, Greece, 115 27
Withdrawn
50
Novartis Investigative Site
Heraklion Crete., Greece, 715 00
Completed
51
Novartis Investigative Site
Thessaloniki, Greece, 546 42
Completed
52
Novartis Investigative Site
Thessaloniki, Greece, 546 42
Withdrawn
53
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110017
Active, Not Recruiting
54
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110029
Active, Not Recruiting
55
Novartis Investigative Site
Hyderabad, Telangana, India, 500058
Withdrawn
56
Novartis Investigative Site
Lucknow, Uttar Pradesh, India, 226014
Active, Not Recruiting
57
Novartis Investigative Site
Dehradun, Uttarakhand, India, 248001
Withdrawn
58
Novartis Investigative Site
Petah Tikva, Israel, 4920235
Completed
59
Novartis Investigative Site
Petah Tikva, Israel, 4941492
Completed
60
Novartis Investigative Site
Ranica, BG, Italy, 24020
Active, Not Recruiting
61
Novartis Investigative Site
Milan, MI, Italy, 20122
Withdrawn
62
Novartis Investigative Site
Roma, RM, Italy, 00165
Active, Not Recruiting
63
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 4668560
Completed
64
Novartis Investigative Site
Asahikawa, Hokkaido, Japan, 0788510
Completed
65
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608543
Completed
66
Novartis Investigative Site
Takatsuki, Osaka, Japan, 5691192
Completed
67
Novartis Investigative Site
Ohtsu, Shiga, Japan, 5202192
Completed
68
Novartis Investigative Site
Niigata, Japan, 9518520
Completed
69
Novartis Investigative Site
Nijmegen, Gelderland, Netherlands, 6500HB
Withdrawn
70
Novartis Investigative Site
Leiden, South Holland, Netherlands, 2333 ZA
Completed
71
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08025
Withdrawn
72
Novartis Investigative Site
Port de Sagunt, Valencia, Spain, 46520
Withdrawn
73
Novartis Investigative Site
Barcelona, Spain, 08035
Withdrawn
74
Novartis Investigative Site
Madrid, Spain, 28041
Completed
75
Novartis Investigative Site
Málaga, Spain, 29010
Withdrawn
76
Novartis Investigative Site
Seville, Spain, 41009
Completed
77
Novartis Investigative Site
Bern, Switzerland, 3010
Active, Not Recruiting
78
Novartis Investigative Site
Lausanne, Switzerland, 1011
Withdrawn
79
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34093
Withdrawn
80
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34098
Withdrawn
81
Novartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye), 38039
Completed
82
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Completed
83
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Withdrawn
84
Novartis Investigative Site
Glasgow, Scotland, United Kingdom, G51 4TF
Withdrawn
85
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Active, Not Recruiting
86
Novartis Investigative Site
London, United Kingdom, W12 0HS
Completed
87
Novartis Investigative Site
London, United Kingdom, WC1N 3JH
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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