Actively Recruiting
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Led by Novartis Pharmaceuticals · Updated on 2026-05-06
540
Participants Needed
161
Research Sites
480 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
CONDITIONS
Official Title
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed part 1 or 2 of the CLNP023X2203 trial or the full 24-month treatment period of the CLNP023A2301 trial
- Estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73m2 or higher
- Investigator judges participant may benefit from iptacopan 200 mg twice daily
- Vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae are up to date according to local guidelines
- Currently on a supportive care regimen with ACE inhibitors or angiotensin receptor blockers (ARB), or have documented allergies or intolerance to these drugs
You will not qualify if you...
- Participants who failed screening or baseline or withdrew prematurely from the CLNP023X2203 or CLNP023A2301 trials
- Evidence of severe urinary obstruction or voiding difficulties or urinary tract disorders other than IgA nephropathy
- Current acute kidney injury within 4 weeks before study drug administration
- Rapidly progressive glomerulonephritis defined by 50% decline in eGFR in the last 3 months
- Treatment with immunosuppressive or immunomodulatory agents such as cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, everolimus, or corticosteroids above 7.5 mg/d prednisone equivalent within 5 half-lives or 90 days prior to study drug administration (rituximab requires 180 days washout)
- Use of other investigational drugs at enrollment or within 5 half-lives or 30 days prior
- History of recurrent invasive infections caused by encapsulated bacteria such as meningococcus or pneumococcus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 161 locations
1
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona, United States, 85306
Actively Recruiting
2
Kaiser Permanente
San Diego, California, United States, 92111
Active, Not Recruiting
3
North America Research Institute
San Dimas, California, United States, 91773
Active, Not Recruiting
4
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Active, Not Recruiting
5
Nephrology Associates PA
Newark, Delaware, United States, 19713
Withdrawn
6
CaRe Research
Chubbuck, Idaho, United States, 83202
Active, Not Recruiting
7
Nep Assoc of Northern Illinois
Hinsdale, Illinois, United States, 60521
Active, Not Recruiting
8
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
9
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States, 02115
Completed
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, United States, 64111
Active, Not Recruiting
12
DaVita Clinical Research
Las Vegas, Nevada, United States, 89146
Active, Not Recruiting
13
New Jersey Kidney Care
Jersey City, New Jersey, United States, 07305
Active, Not Recruiting
14
Col Uni Med Center New York Presby
New York, New York, United States, 10032
Actively Recruiting
15
Dallas Renal Group
Dallas, Texas, United States, 75230
Active, Not Recruiting
16
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Withdrawn
17
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina, 5000
Active, Not Recruiting
18
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina, X5016KEH
Active, Not Recruiting
19
Novartis Investigative Site
CABA, Argentina, C1181ACH
Active, Not Recruiting
20
Novartis Investigative Site
CABA, Argentina, C1426ABP
Active, Not Recruiting
21
Novartis Investigative Site
Santa Fe, Argentina, S3000EPV
Active, Not Recruiting
22
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102
Active, Not Recruiting
23
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Active, Not Recruiting
24
Novartis Investigative Site
Parkville, Victoria, Australia, 3065
Active, Not Recruiting
25
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium, 8800
Active, Not Recruiting
26
Novartis Investigative Site
Edegem, Belgium, 2650
Active, Not Recruiting
27
Novartis Investigative Site
Leuven, Belgium, 3000
Active, Not Recruiting
28
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Active, Not Recruiting
29
Novartis Investigative Site
Curitiba, Paraná, Brazil, 80440-020
Active, Not Recruiting
30
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Active, Not Recruiting
31
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04038-002
Active, Not Recruiting
32
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
Active, Not Recruiting
33
Novartis Investigative Site
Sao Jose Rio Preto, Brazil, 15090 000
Active, Not Recruiting
34
Novartis Investigative Site
Oshawa, Ontario, Canada, L1G 2B9
Withdrawn
35
Novartis Investigative Site
Temuco, Chile, 4781151
Active, Not Recruiting
36
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100013
Active, Not Recruiting
37
Novartis Investigative Site
Beijing, Beijing Municipality, China, 102218
Active, Not Recruiting
38
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
Active, Not Recruiting
39
Novartis Investigative Site
Luoyang, Henan, China, 471003
Completed
40
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
Active, Not Recruiting
41
Novartis Investigative Site
Changsha, Hunan, China, 410011
Active, Not Recruiting
42
Novartis Investigative Site
Changchun, Jilin, China, 130041
Active, Not Recruiting
43
Novartis Investigative Site
Yinchuan, Ningxia, China, 750004
Active, Not Recruiting
44
Novartis Investigative Site
Taiyuan, Shanxi, China, 030001
Active, Not Recruiting
45
Novartis Investigative Site
Xian, Shanxi, China, 710061
Active, Not Recruiting
46
Novartis Investigative Site
Ürümqi, Xinjiang, China, 830001
Active, Not Recruiting
47
Novartis Investigative Site
Ningbo, Zhejiang, China, 315016
Active, Not Recruiting
48
Novartis Investigative Site
Wenzhou, Zhejiang, China, 325000
Active, Not Recruiting
49
Novartis Investigative Site
Beijing, China, 100034
Active, Not Recruiting
50
Novartis Investigative Site
Guangzhou, China, 510080
Active, Not Recruiting
51
Novartis Investigative Site
Ningbo, China, 315010
Active, Not Recruiting
52
Novartis Investigative Site
Qingdao, China, 266000
Active, Not Recruiting
53
Novartis Investigative Site
Shanghai, China, 200025
Active, Not Recruiting
54
Novartis Investigative Site
Shanghai, China, 200040
Active, Not Recruiting
55
Novartis Investigative Site
Shenzhen, China, 518036
Active, Not Recruiting
56
Novartis Investigative Site
Medellín, Antioquia, Colombia, 050001
Active, Not Recruiting
57
Novartis Investigative Site
Barranquilla, Atlántico, Colombia, 080020
Active, Not Recruiting
58
Novartis Investigative Site
Prague, Czechia, 128 08
Active, Not Recruiting
59
Novartis Investigative Site
Aalborg, Denmark, 9000
Active, Not Recruiting
60
Novartis Investigative Site
Aarhus N, Denmark, 8200
Active, Not Recruiting
61
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Active, Not Recruiting
62
Novartis Investigative Site
Odense C, Denmark, 5000
Active, Not Recruiting
63
Novartis Investigative Site
Marseille, France, 13005
Active, Not Recruiting
64
Novartis Investigative Site
Montpellier, France, 34295
Active, Not Recruiting
65
Novartis Investigative Site
Paris, France, 75015
Active, Not Recruiting
66
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Active, Not Recruiting
67
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, Germany, 70376
Active, Not Recruiting
68
Novartis Investigative Site
Aachen, Germany, 52074
Active, Not Recruiting
69
Novartis Investigative Site
Berlin, Germany, 13353
Active, Not Recruiting
70
Novartis Investigative Site
Essen, Germany, 45147
Active, Not Recruiting
71
Novartis Investigative Site
Hanover, Germany, 30625
Active, Not Recruiting
72
Novartis Investigative Site
Heidelberg, Germany, 69120
Withdrawn
73
Novartis Investigative Site
Kiel, Germany, 24105
Active, Not Recruiting
74
Novartis Investigative Site
Magdeburg, Germany, 39120
Active, Not Recruiting
75
Novartis Investigative Site
Mainz, Germany, 55131
Active, Not Recruiting
76
Novartis Investigative Site
Tübingen, Germany, 72076
Active, Not Recruiting
77
Novartis Investigative Site
Ulm, Germany, 89081
Active, Not Recruiting
78
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong, 999077
Active, Not Recruiting
79
Novartis Investigative Site
Pécs, Baranya, Hungary, 7623
Active, Not Recruiting
80
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Active, Not Recruiting
81
Novartis Investigative Site
Bangalore, Karnataka, India, 560004
Active, Not Recruiting
82
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110017
Active, Not Recruiting
83
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110029
Active, Not Recruiting
84
Novartis Investigative Site
Hyderabad, Telangana, India, 500082
Active, Not Recruiting
85
Novartis Investigative Site
Ashkelon, Israel, 7830604
Active, Not Recruiting
86
Novartis Investigative Site
Jerusalem, Israel, 9112001
Active, Not Recruiting
87
Novartis Investigative Site
Petah Tikva, Israel, 4941492
Active, Not Recruiting
88
Novartis Investigative Site
Bologna, BO, Italy, 40138
Active, Not Recruiting
89
Novartis Investigative Site
Naples, Italy, 80131
Active, Not Recruiting
90
Novartis Investigative Site
Kasugai, Aichi-ken, Japan, 486-8510
Active, Not Recruiting
91
Novartis Investigative Site
Toyoake, Aichi-ken, Japan, 4701192
Active, Not Recruiting
92
Novartis Investigative Site
Toyota, Aichi-ken, Japan, 471-8513
Active, Not Recruiting
93
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0068555
Active, Not Recruiting
94
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608604
Active, Not Recruiting
95
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 213-8587
Active, Not Recruiting
96
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 224-8503
Active, Not Recruiting
97
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 236-0004
Active, Not Recruiting
98
Novartis Investigative Site
Kyoto, Kyoto, Japan, 605-0981
Active, Not Recruiting
99
Novartis Investigative Site
Sendai, Miyagi, Japan, 9813205
Withdrawn
100
Novartis Investigative Site
Matsumoto, Nagano, Japan, 3908621
Active, Not Recruiting
101
Novartis Investigative Site
Osaka, Osaka, Japan, 5340021
Active, Not Recruiting
102
Novartis Investigative Site
Ōmihachiman, Shiga, Japan, 523-0082
Active, Not Recruiting
103
Novartis Investigative Site
Chiba, Japan, 2608712
Active, Not Recruiting
104
Novartis Investigative Site
Niigata, Japan, 9518520
Active, Not Recruiting
105
Novartis Investigative Site
Okayama, Japan, 7008558
Active, Not Recruiting
106
Novartis Investigative Site
Osaka, Japan, 5300012
Active, Not Recruiting
107
Novartis Investigative Site
Osaka, Japan, 5308480
Active, Not Recruiting
108
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
Active, Not Recruiting
109
Novartis Investigative Site
Kuala Lumpur, Malaysia, 59100
Active, Not Recruiting
110
Novartis Investigative Site
Benito Juárez, Mexico City, Mexico, 03100
Actively Recruiting
111
Novartis Investigative Site
Querétaro, Mexico, 76000
Actively Recruiting
112
Novartis Investigative Site
Groningen, Provincie Groningen, Netherlands, 9713 GZ
Active, Not Recruiting
113
Novartis Investigative Site
Nordbyhagen, Oslo, Norway, 1478
Active, Not Recruiting
114
Novartis Investigative Site
Bergen, Norway, NO-5021
Active, Not Recruiting
115
Novartis Investigative Site
Rostov-on-Don, Russia, 344022
Active, Not Recruiting
116
Novartis Investigative Site
Saint Petersburg, Russia, 197110
Active, Not Recruiting
117
Novartis Investigative Site
Singapore, Singapore, 119074
Active, Not Recruiting
118
Novartis Investigative Site
Singapore, Singapore, 169608
Active, Not Recruiting
119
Novartis Investigative Site
Košice, Slovakia, 040 11
Active, Not Recruiting
120
Novartis Investigative Site
Maribor, Slovenia, Slovenia, 2000
Withdrawn
121
Novartis Investigative Site
Ljubljana, Slovenia, 1000
Active, Not Recruiting
122
Novartis Investigative Site
Bloemfontein, Free State, South Africa, 9301
Active, Not Recruiting
123
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea, 13620
Active, Not Recruiting
124
Novartis Investigative Site
Seoul, Korea, South Korea, 02841
Completed
125
Novartis Investigative Site
Seoul, Korea, South Korea, 03312
Active, Not Recruiting
126
Novartis Investigative Site
Cheongju-si, North Chungcheong, South Korea, 28644
Active, Not Recruiting
127
Novartis Investigative Site
Seoul, Seoul, South Korea, 03080
Active, Not Recruiting
128
Novartis Investigative Site
Busan, South Korea, 47392
Active, Not Recruiting
129
Novartis Investigative Site
Seoul, South Korea, 03722
Active, Not Recruiting
130
Novartis Investigative Site
Seoul, South Korea, 06591
Active, Not Recruiting
131
Novartis Investigative Site
Seoul, South Korea, 06973
Active, Not Recruiting
132
Novartis Investigative Site
Seoul, South Korea, 134 727
Active, Not Recruiting
133
Novartis Investigative Site
Taegu, South Korea, 41944
Active, Not Recruiting
134
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Active, Not Recruiting
135
Novartis Investigative Site
Barcelona, Spain, 08036
Active, Not Recruiting
136
Novartis Investigative Site
Salamanca, Spain, 37007
Active, Not Recruiting
137
Novartis Investigative Site
Stockholm, Sweden, 141 86
Active, Not Recruiting
138
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Active, Not Recruiting
139
Novartis Investigative Site
New Taipei City, Taiwan, 22060
Active, Not Recruiting
140
Novartis Investigative Site
New Taipei City, Taiwan, 23561
Active, Not Recruiting
141
Novartis Investigative Site
Taichung, Taiwan, 40447
Active, Not Recruiting
142
Novartis Investigative Site
Taichung, Taiwan, 407219
Completed
143
Novartis Investigative Site
Taipei, Taiwan, 10002
Active, Not Recruiting
144
Novartis Investigative Site
Taoyuan, Taiwan, 33305
Active, Not Recruiting
145
Novartis Investigative Site
Bangkok, Thailand, 10330
Active, Not Recruiting
146
Novartis Investigative Site
Bangkok, Thailand, 10400
Active, Not Recruiting
147
Novartis Investigative Site
Bangkok, Thailand, 10700
Active, Not Recruiting
148
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34098
Active, Not Recruiting
149
Novartis Investigative Site
Köseköy, Kocaeli, Turkey (Türkiye), 41380
Active, Not Recruiting
150
Novartis Investigative Site
Antalya, Konyaalti, Turkey (Türkiye), 07070
Active, Not Recruiting
151
Novartis Investigative Site
Kayseri, Melikgazi, Turkey (Türkiye), 38039
Active, Not Recruiting
152
Novartis Investigative Site
Istanbul, Sariyer, Turkey (Türkiye), 34396
Active, Not Recruiting
153
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Active, Not Recruiting
154
Novartis Investigative Site
Mersin, Yenisehir, Turkey (Türkiye), 33110
Active, Not Recruiting
155
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Active, Not Recruiting
156
Novartis Investigative Site
Cambridge, United Kingdom, CB2 0QQ
Active, Not Recruiting
157
Novartis Investigative Site
Leicester, United Kingdom, LE5 4PW
Active, Not Recruiting
158
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Active, Not Recruiting
159
Novartis Investigative Site
Salford, United Kingdom, M6 8HD
Active, Not Recruiting
160
Novartis Investigative Site
Ho Chi Minh City, VNM, Vietnam, 700000
Active, Not Recruiting
161
Novartis Investigative Site
Ho Chi Minh City, Vietnam, 700000
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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