Actively Recruiting
Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)
Led by Novartis Pharmaceuticals · Updated on 2026-06-01
106
Participants Needed
130
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of iptacopan (LNP023) in people aged 12 to 60 years with idiopathic immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). This Phase III, multicenter study compares iptacopan combined with standard care to a placebo combined with standard care. The study focuses on reducing proteinuria, improving kidney function measured by estimated glomerular filtration rate (eGFR), and assessing changes in patient-reported fatigue. The trial recognizes that dysregulation of the alternative complement pathway contributes to IC-MPGN progression. Participants will be randomly assigned to receive either iptacopan 200 mg twice daily or a matching placebo twice daily, both alongside their usual care. The study includes a double-blind treatment period lasting up to 18 months. After completing the treatment phase, participants may either stop iptacopan and enter a 30-day safety follow-up or continue iptacopan treatment in an open-label extension study. During the trial, participants will undergo regular assessments including 24-hour urine collections to measure proteinuria, blood tests to evaluate kidney function, and questionnaires to assess fatigue levels. Researchers will monitor vital signs, heart function, and laboratory safety results throughout the study. The main outcome is the change in urine protein levels at 6 months, with additional kidney function and fatigue measurements at 12 and 18 months. The total participation may last up to 18 months, including safety follow-up or extension phases.
CONDITIONS
Brief Title
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 to 60 years (adolescents 12-17 years in non-EU countries; 16-17 years in EU countries at screening)
- Diagnosis of idiopathic IC-MPGN confirmed by kidney biopsy within 12 months for adults and within 3 years for adolescents
- On stable, maximally recommended or tolerated doses of renin angiotensin system inhibitors (e.g., ACEi or ARB) for at least 90 days prior to randomization
- Stable doses of other proteinuria-controlling drugs (mycophenolic acids, corticosteroids, SGLT2 inhibitors, mineralocorticoid receptor antagonists) for at least 90 days prior to randomization
- Urine protein to creatinine ratio (UPCR) ≥ 1.0 g/g from first morning void urine samples at Day -75 and Day -15
- Estimated or measured glomerular filtration rate (eGFR or GFR) ≥ 30 ml/min/1.73m2 at screening and Day -15
- Vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and if available, Haemophilus influenzae at least 2 weeks before starting study treatment or receiving prophylactic antibiotics if vaccination timing is shorter
You will not qualify if you...
- History of cell or solid organ transplantation including kidney transplant
- Diagnosis of secondary IC-MPGN caused by chronic infections (e.g., hepatitis B or C, bacterial endocarditis, meningitis), systemic autoimmune diseases (e.g., lupus, Sjögren syndrome, rheumatoid arthritis), or monoclonal gammopathy
- Fibrillary glomerulonephritis
- Rapidly progressive crescentic glomerulonephritis with ≥50% crescent formation on recent biopsy
- Kidney biopsy showing more than 50% interstitial fibrosis/tubular atrophy
- Active systemic bacterial, viral, or fungal infection within 14 days before treatment or fever ≥ 38°C within 7 days before treatment
- History of recurrent invasive infections by encapsulated organisms
- Use of complement inhibitors within 3 months or 5 half-lives before screening
- Use of immunosuppressants (except mycophenolic acids), cyclophosphamide, or systemic corticosteroids above 7.5 mg/day within 90 days before study drug
- Use of mycophenolic acids within 90 days before randomization in India
- Acute post-infectious glomerulonephritis at screening
- Body mass index over 38 kg/m2 or body weight under 35 kg at screening and randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive either iptacopan or placebo, both in combination with standard of care, to evaluate changes in proteinuria, kidney function, and fatigue.
Regular visits during the 18-month treatment period
Duration - 30 days
Participants may enter a 30-day safety follow-up period after treatment completion if they do not continue into the open label extension study.
1 follow-up visit (in-person)
Trial Site Locations
Total: 130 locations
1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Univ Cali Irvine ALS Neuromuscular
Orange, California, United States, 92868
Actively Recruiting
3
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
4
Olive View UCLA Medical Center
Sylmar, California, United States, 91342
Actively Recruiting
5
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Nicklaus Childrens Hospital
Miami, Florida, United States, 33155
Actively Recruiting
7
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Boston Univ School of Medicine
Boston, Massachusetts, United States, 02118
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
Washington University in St Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
12
University of New Mexico
Albuquerque, New Mexico, United States, 87131-0001
Actively Recruiting
13
Col Uni Med Center New York Presby
New York, New York, United States, 10032
Actively Recruiting
14
University Of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
15
OHSU Dept of Nephrology
Portland, Oregon, United States, 97239
Actively Recruiting
16
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
17
MUSC Health Lancaster Med Ctr
Lancaster, South Carolina, United States, 29720
Actively Recruiting
18
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
19
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
20
Baylor Scott and White Research
Temple, Texas, United States, 76502
Actively Recruiting
21
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
22
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
23
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425AGC
Actively Recruiting
24
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425EFD
Actively Recruiting
25
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina, X5000
Actively Recruiting
26
Novartis Investigative Site
Buenos Aires, Argentina, W3400ABH
Actively Recruiting
27
Novartis Investigative Site
CABA, Argentina, C1181ACH
Actively Recruiting
28
Novartis Investigative Site
Santa Fe, Argentina, S3000EPV
Actively Recruiting
29
Novartis Investigative Site
Fortaleza, Ceará, Brazil, 60430 370
Actively Recruiting
30
Novartis Investigative Site
Brasília, Federal District, Brazil, 71635-580
Withdrawn
31
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Actively Recruiting
32
Novartis Investigative Site
Recife, Pernambuco, Brazil, 50740-900
Actively Recruiting
33
Novartis Investigative Site
Niterói, Rio de Janeiro, Brazil, 24020 096
Withdrawn
34
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil, 22211-230
Withdrawn
35
Novartis Investigative Site
Natal, Rio Grande do Norte, Brazil, 59012 300
Actively Recruiting
36
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Actively Recruiting
37
Novartis Investigative Site
Botucatu, São Paulo, Brazil, 18618-970
Actively Recruiting
38
Novartis Investigative Site
Santo André, São Paulo, Brazil, 09090-790
Actively Recruiting
39
Novartis Investigative Site
Sao Jose Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
40
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04038-002
Actively Recruiting
41
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
Withdrawn
42
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
43
Novartis Investigative Site
Salvador, Brazil, 40323-010
Actively Recruiting
44
Novartis Investigative Site
Etobicoke, Ontario, Canada, M9W 6V1
Actively Recruiting
45
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
46
Novartis Investigative Site
Montreal, Quebec, Canada, H2X 1R9
Actively Recruiting
47
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
48
Novartis Investigative Site
Prague, Czechia, 128 08
Actively Recruiting
49
Novartis Investigative Site
Aarhus N, Denmark, 8200
Actively Recruiting
50
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Actively Recruiting
51
Novartis Investigative Site
Marseille, France, 13005
Actively Recruiting
52
Novartis Investigative Site
Montpellier, France, 34295
Actively Recruiting
53
Novartis Investigative Site
Paris, France, 75015
Actively Recruiting
54
Novartis Investigative Site
Rennes, France, 35033
Actively Recruiting
55
Novartis Investigative Site
Toulouse, France, 31054
Actively Recruiting
56
Novartis Investigative Site
Munich, Bavaria, Germany, 81377
Actively Recruiting
57
Novartis Investigative Site
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
58
Novartis Investigative Site
Dresden, Saxony, Germany, 01307
Actively Recruiting
59
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
60
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
61
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
62
Novartis Investigative Site
Hamburg, Germany, 20246
Actively Recruiting
63
Novartis Investigative Site
Hanover, Germany, 30625
Actively Recruiting
64
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
65
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
66
Novartis Investigative Site
Athens, Greece, 115 27
Actively Recruiting
67
Novartis Investigative Site
Chaïdári, Greece, 124 62
Actively Recruiting
68
Novartis Investigative Site
Heraklion Crete., Greece, 715 00
Actively Recruiting
69
Novartis Investigative Site
Ioannina, Greece, 455 00
Actively Recruiting
70
Novartis Investigative Site
Pátrai, Greece, 265 04
Actively Recruiting
71
Novartis Investigative Site
Thessaloniki, Greece, 54636
Actively Recruiting
72
Novartis Investigative Site
Thessaloniki, Greece, 570 10
Actively Recruiting
73
Novartis Investigative Site
Bangalore, Karnataka, India, 560004
Actively Recruiting
74
Novartis Investigative Site
Nagpur, Maharashtra, India, 440015
Actively Recruiting
75
Novartis Investigative Site
Pune, Maharashtra, India, 411011
Actively Recruiting
76
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
77
Novartis Investigative Site
Hyderabad, Telangana, India, 500082
Actively Recruiting
78
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
79
Novartis Investigative Site
Jerusalem, Israel, 9103102
Actively Recruiting
80
Novartis Investigative Site
Petah Tikva, Israel, 4920235
Actively Recruiting
81
Novartis Investigative Site
Bari, BA, Italy, 70124
Actively Recruiting
82
Novartis Investigative Site
Ranica, BG, Italy, 24020
Actively Recruiting
83
Novartis Investigative Site
Brescia, BS, Italy, 25123
Actively Recruiting
84
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
85
Novartis Investigative Site
Roma, RM, Italy, 00165
Actively Recruiting
86
Novartis Investigative Site
Torino, TO, Italy, 10126
Actively Recruiting
87
Novartis Investigative Site
Naples, Italy, 80131
Actively Recruiting
88
Novartis Investigative Site
Toyoake, Aichi-ken, Japan, 4701192
Actively Recruiting
89
Novartis Investigative Site
Fuchū, Tokyo, Japan, 1838561
Actively Recruiting
90
Novartis Investigative Site
Hachiōji, Tokyo, Japan, 193-0998
Actively Recruiting
91
Novartis Investigative Site
Okayama, Japan, 7008558
Actively Recruiting
92
Novartis Investigative Site
Osaka, Japan, 558-8558
Actively Recruiting
93
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ
Actively Recruiting
94
Novartis Investigative Site
Poznan, Greater Poland Voivodeship, Poland, 60-355
Actively Recruiting
95
Novartis Investigative Site
Bialystok, Poland, 15-540
Actively Recruiting
96
Novartis Investigative Site
Krakow, Poland, 30-688
Actively Recruiting
97
Novartis Investigative Site
Olsztyn, Poland, 10-561
Actively Recruiting
98
Novartis Investigative Site
Warsaw, Poland, 02-006
Actively Recruiting
99
Novartis Investigative Site
Warsaw, Poland, 02-097
Actively Recruiting
100
Novartis Investigative Site
Wroclaw, Poland, 50-417
Withdrawn
101
Novartis Investigative Site
Martin, Slovakia, Slovakia, 036 59
Actively Recruiting
102
Novartis Investigative Site
Banská Bystrica, Slovakia, 975 17
Actively Recruiting
103
Novartis Investigative Site
Košice, Slovakia, 041 90
Actively Recruiting
104
Novartis Investigative Site
Seoul, Seoul, South Korea, 03080
Actively Recruiting
105
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
106
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
107
Novartis Investigative Site
Almería, Spain, 04009
Actively Recruiting
108
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
109
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
110
Novartis Investigative Site
Madrid, Spain, 28040
Actively Recruiting
111
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
112
Novartis Investigative Site
Madrid, Spain, 280796
Actively Recruiting
113
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
114
Novartis Investigative Site
Bern, Switzerland, 3010
Actively Recruiting
115
Novartis Investigative Site
Lausanne, Switzerland, 1011
Withdrawn
116
Novartis Investigative Site
Zurich, Switzerland, 8091
Actively Recruiting
117
Novartis Investigative Site
Kaohsiung City, Taiwan, 81346
Actively Recruiting
118
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34093
Actively Recruiting
119
Novartis Investigative Site
Izmir, Karsiyaka, Turkey (Türkiye), 35575
Actively Recruiting
120
Novartis Investigative Site
Köseköy, Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
121
Novartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye), 38039
Actively Recruiting
122
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Actively Recruiting
123
Novartis Investigative Site
Mersin, Yenisehir, Turkey (Türkiye), 33110
Actively Recruiting
124
Novartis Investigative Site
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
125
Novartis Investigative Site
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
126
Novartis Investigative Site
London, United Kingdom, NW3 2QG
Actively Recruiting
127
Novartis Investigative Site
London, United Kingdom, WC1N 3JH
Actively Recruiting
128
Novartis Investigative Site
Manchester, United Kingdom, M13 9WL
Actively Recruiting
129
Novartis Investigative Site
Salford, United Kingdom, M6 8HD
Actively Recruiting
130
Novartis Investigative Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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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