Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
Start Date
10/2/2023
Completion Date
5/31/2029
Summary
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
Detailed Description
The purpose of this Phase III study is to evaluate the efficacy and safety of iptacopan compared to placebo (both administered in combination with standard of care) in participants (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN. The study aims to demonstrate a reduction in proteinuria and improvement in estimated glomerular filtration rate (eGFR) in participants treated with iptacopan compared to placebo. Change in patient-reported fatigue will also be evaluated. Alternative complement pathway (AP) dysregulation is believed to underlie the clinical manifestations and progression of IC-MPGN. Upon completion of study treatment, participants will have the option to discontinue iptacopan treatment and enter a 30 day safety follow-up or continue iptacopan treatment by transitioning to an open label extension study (CLNP023B12001B; NCT03955445) and continue iptacopan treatment.
Eligibility Criteria
Age Range: 12 years to 60 years
Interventions
Placebo
iptacopan
Conditions
Locations
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Univ Cali Irvine ALS Neuromuscular
Orange, California 92868
United States
UCSF
San Francisco, California 94115
United States
Olive View UCLA Medical Center
Sylmar, California 91342
United States
Childrens Hospital Colorado
Aurora, Colorado 80045
United States
Nicklaus Childrens Hospital
Miami, Florida 33155
United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia 30322
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Boston Univ School of Medicine
Boston, Massachusetts 02118
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Washington University in St Louis
St Louis, Missouri 63110
United States
University of New Mexico
Albuquerque, New Mexico 87131-0001
United States
Col Uni Med Center New York Presby
New York, New York 10032
United States
University Of Cincinnati
Cincinnati, Ohio 45267
United States
OHSU Dept of Nephrology
Portland, Oregon 97239
United States
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104
United States
MUSC Health Lancaster Med Ctr
Lancaster, South Carolina 29720
United States
UT Southwestern Medical Center
Dallas, Texas 75235
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
Baylor Scott and White Research
Temple, Texas 76502
United States
University of Utah
Salt Lake City, Utah 84113
United States
University of Wisconsin
Madison, Wisconsin 53792
United States
Novartis Investigative Site
CABA, Buenos Aires C1425AGC
Argentina
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CABA, Buenos Aires C1425EFD
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Córdoba, Córdoba Province X5000
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Buenos Aires, W3400ABH
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CABA, C1181ACH
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Santa Fe, S3000EPV
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Fortaleza, Ceará 60430 370
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Brasília, Federal District 71635-580
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Belo Horizonte, Minas Gerais 30150-221
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Recife, Pernambuco 50740-900
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Niterói, Rio de Janeiro 24020 096
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Rio de Janeiro, Rio de Janeiro 22211-230
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Natal, Rio Grande do Norte 59012 300
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Porto Alegre, Rio Grande do Sul 90035-074
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Botucatu, São Paulo 18618-970
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Santo André, São Paulo 09090-790
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Sao Jose Rio Preto, São Paulo 15090-000
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São Paulo, São Paulo 04038-002
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São Paulo, São Paulo 05403 000
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São Paulo, São Paulo 05403-000
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Salvador, 40323-010
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Etobicoke, Ontario M9W 6V1
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London, Ontario N6A 5W9
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Toronto, Ontario M5G 2C4
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Montreal, Quebec H2X 1R9
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Montreal, Quebec H3T 1C5
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Prague, 128 08
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Aarhus N, 8200
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Copenhagen, DK-2100
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Marseille, 13005
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Montpellier, 34295
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Paris, 75015
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Rennes, 35033
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Toulouse, 31054
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Munich, Bavaria 81377
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Würzburg, Bavaria 97080
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Dresden, Saxony 01307
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Jena, Thuringia 07740
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Berlin, 13353
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Essen, 45147
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Hamburg, 20246
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Hanover, 30625
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Mainz, 55131
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Ulm, 89081
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Athens, 115 27
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Chaïdári, 124 62
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Heraklion Crete., 715 00
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Ioannina, 455 00
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Pátrai, 265 04
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Thessaloniki, 54636
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Thessaloniki, 570 10
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Bangalore, Karnataka 560004
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Nagpur, Maharashtra 440015
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Pune, Maharashtra 411011
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New Delhi, National Capital Territory of Delhi 110029
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Hyderabad, Telangana 500082
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Haifa, 3109601
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Jerusalem, 9103102
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Petah Tikva, 4920235
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Bari, BA 70124
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Ranica, BG 24020
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Brescia, BS 25123
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Milan, MI 20122
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Roma, RM 00165
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Torino, TO 10126
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Naples, 80131
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Toyoake, Aichi-ken 4701192
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Fuchū, Tokyo 1838561
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Hachiōji, Tokyo 193-0998
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Okayama, 7008558
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Osaka, 558-8558
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Groningen, 9713 GZ
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Poznan, Greater Poland Voivodeship 60-355
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Bialystok, 15-540
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Krakow, 30-688
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Martin, Slovakia 036 59
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Banská Bystrica, 975 17
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Košice, 041 90
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Seoul, 03722
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Pamplona, Navarre 31008
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Barcelona, 08036
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Madrid, 28040
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Madrid, 280796
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Salamanca, 37007
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Bern, 3010
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Lausanne, 1011
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Zurich, 8091
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Kaohsiung City, 81346
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Istanbul, Fatih 34093
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Izmir, Karsiyaka 35575
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Köseköy, Kocaeli 41380
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Kayseri, Melikgazi 38039
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Mersin, Yenisehir 33110
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Salford, M6 8HD
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Ho Chi Minh City, 700000
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