Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Start Date
7/28/2021
Completion Date
1/29/2027
Summary
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.
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to placebo and standard of care in patients with native C3G. CLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants treated with iptacopan compared to placebo, as well as the proportion of participants who achieve a composite renal endpoint consisting of eGFR and UPCR elements. These effects of iptacopan in conjunction with increases in serum C3 levels will provide support for an iptacopan profile that includes stabilization of eGFR, clinically meaningful reductions in proteinuria and inhibition of the complement AP. Kidney biopsies will be performed in adult participants to evaluate histopathological improvements in immunofluorescence and light microscopy that support these functional benefits of iptacopan.
Eligibility Criteria
Age Range: 12 years to 60 years
Interventions
Placebo
iptacopan
Conditions
Locations
Childrens Hospital Colorado
Aurora, Colorado 80045
United States
Nicklaus Childrens Hospital
Miami, Florida 33155
United States
Georgia Nephrology Research Inst
Lawrenceville, Georgia 30046
United States
IN University School of Med
Indianapolis, Indiana 46202-5111
United States
University of Iowa Health Care
Iowa City, Iowa 52242-1091
United States
University of Iowa Health Care
Iowa City, Iowa 52242
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts 02115
United States
Hackensack Uni Medical Center
Hackensack, New Jersey 07601
United States
Albany Medical Center
Albany, New York 12208
United States
Col Uni Med Center New York Presby
New York, New York 10032
United States
Baylor Scott and White Research
Temple, Texas 76502
United States
University of Wisconsin
Madison, Wisconsin 53792
United States
Novartis Investigative Site
Córdoba, Córdoba Province X5016KET
Argentina
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Buenos Aires, W3400ABH
Argentina
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CABA, C1181ACH
Argentina
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Edegem, 2650
Belgium
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Leuven, 3000
Belgium
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Belo Horizonte, Minas Gerais 30150-221
Brazil
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Recife, Pernambuco 50740-900
Brazil
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Passo Fundo, Rio Grande do Sul 99010-260
Brazil
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Joinville, Santa Catarina 89227-680
Brazil
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Santo André, São Paulo 09090-790
Brazil
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São Paulo, São Paulo 04038-002
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São Paulo, São Paulo 05403 000
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Salvador, 40323-010
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London, Ontario N6A 5W9
Canada
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Toronto, Ontario M5G 2C4
Canada
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Montreal, Quebec H3T 1C5
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Guangzhou, Guangdong 510080
China
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Wuhan, Hubei 430022
China
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Beijing, 100034
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Beijing, 100730
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Shanghai, 200040
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Prague, 128 08
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Lille, 59037
France
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Marseille, 13005
France
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Montpellier, 34295
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Paris, 75015
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Paris, 75019
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Cologne, North Rhine-Westphalia 50937
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Aachen, 52074
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Erlangen, 91054
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Essen, 45147
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Hamburg, 20246
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Hanover, 30625
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Heidelberg, 69120
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Mainz, 55131
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Athens, 115 27
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Heraklion Crete., 715 00
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Thessaloniki, 546 42
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Thessaloniki, 546 42
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New Delhi, National Capital Territory of Delhi 110017
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New Delhi, National Capital Territory of Delhi 110029
India
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Hyderabad, Telangana 500058
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Lucknow, Uttar Pradesh 226014
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Dehradun, Uttarakhand 248001
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Petah Tikva, 4920235
Israel
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Petah Tikva, 4941492
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Ranica, BG 24020
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Milan, MI 20122
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Roma, RM 00165
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Nagoya, Aichi-ken 4668560
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Asahikawa, Hokkaido 0788510
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Sapporo, Hokkaido 0608543
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Takatsuki, Osaka 5691192
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Ohtsu, Shiga 5202192
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Niigata, 9518520
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Nijmegen, Gelderland 6500HB
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Leiden, South Holland 2333 ZA
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Barcelona, Catalonia 08025
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Port de Sagunt, Valencia 46520
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Barcelona, 08035
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Madrid, 28041
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Málaga, 29010
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Seville, 41009
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Bern, 3010
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Lausanne, 1011
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Istanbul, Fatih 34093
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Istanbul, Fatih 34098
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Kayseri, Melikgazi 38039
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Ankara, Yenimahalle 06500
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Ankara, Yenimahalle 06500
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Glasgow, Scotland G51 4TF
United Kingdom
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Newcastle upon Tyne, Tyne and Wear NE1 4LP
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London, W12 0HS
United Kingdom
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London, WC1N 3JH
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