RecruitingPhase 3NCT05755386

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

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 (IC-MPGN)


Sponsor

Novartis Pharmaceuticals

Enrollment

106 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called iptacopan for people with ic-mpgn. The study is currently recruiting participants at 127 locations. People eligible for this study include aged 12 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

DRUGiptacopan

iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)


Locations(131)

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Univ Cali Irvine ALS Neuromuscular

Orange, California, United States

UCSF

San Francisco, California, United States

Olive View UCLA Medical Center

Sylmar, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Nicklaus Childrens Hospital

Miami, Florida, United States

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Univ School of Medicine

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University in St Louis

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

Col Uni Med Center New York Presby

New York, New York, United States

University Of Cincinnati

Cincinnati, Ohio, United States

OHSU Dept of Nephrology

Portland, Oregon, United States

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

MUSC Health Lancaster Med Ctr

Lancaster, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Baylor Scott and White Research

Temple, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Wisconsin

Madison, Wisconsin, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Buenos Aires, Argentina

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CABA, Argentina

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Santa Fe, Argentina

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Fortaleza, Ceará, Brazil

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Brasília, Federal District, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Recife, Pernambuco, Brazil

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Niterói, Rio de Janeiro, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Natal, Rio Grande do Norte, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Botucatu, São Paulo, Brazil

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Santo André, São Paulo, Brazil

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Sao Jose Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Salvador, Brazil

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Prague, Czechia

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Aarhus N, Denmark

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Copenhagen, Denmark

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Marseille, France

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Montpellier, France

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Paris, France

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Rennes, France

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Toulouse, France

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Munich, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Dresden, Saxony, Germany

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Jena, Thuringia, Germany

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Berlin, Germany

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Essen, Germany

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Hamburg, Germany

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Hanover, Germany

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Mainz, Germany

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Ulm, Germany

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Athens, Greece

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Chaïdári, Greece

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Heraklion Crete., Greece

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Ioannina, Greece

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Pátrai, Greece

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Thessaloniki, Greece

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Thessaloniki, Greece

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Bangalore, Karnataka, India

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Nagpur, Maharashtra, India

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Pune, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Hyderabad, Telangana, India

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Haifa, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Bari, BA, Italy

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Ranica, BG, Italy

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Brescia, BS, Italy

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Milan, MI, Italy

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Roma, RM, Italy

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Torino, TO, Italy

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Naples, Italy

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Toyoake, Aichi-ken, Japan

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Fuchū, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Okayama, Japan

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Osaka, Japan

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Groningen, Netherlands

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Poznan, Greater Poland Voivodeship, Poland

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Bialystok, Poland

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Krakow, Poland

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Olsztyn, Poland

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Warsaw, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Martin, Slovakia, Slovakia

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Banská Bystrica, Slovakia

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Košice, Slovakia

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Seoul, Seoul, South Korea

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Seoul, South Korea

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Pamplona, Navarre, Spain

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Almería, Spain

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Salamanca, Spain

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Bern, Switzerland

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Lausanne, Switzerland

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Zurich, Switzerland

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Kaohsiung City, Taiwan

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Istanbul, Fatih, Turkey (Türkiye)

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Izmir, Karsiyaka, Turkey (Türkiye)

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Köseköy, Kocaeli, Turkey (Türkiye)

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Kayseri, Melikgazi, Turkey (Türkiye)

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Ankara, Yenimahalle, Turkey (Türkiye)

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Mersin, Yenisehir, Turkey (Türkiye)

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Belfast, United Kingdom

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Cardiff, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Salford, United Kingdom

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Ho Chi Minh City, Vietnam

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NCT05755386


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