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Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

NCT ID: NCT04578834

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2025-09-19

Brief Summary

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The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Detailed Description

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The purpose of the study is to evaluate the efficacy and safety of iptacopan (LNP023) compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. The study will be the pivotal trial for registration of LNP023 in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in proteinuria by LNP023 vs. placebo as assessed by reduction in urine protein to creatinine ratio (UPCR) sampled from a 24 hour urine collection at an IA at 9 months. The trial will continue in a blinded fashion to confirm long-term efficacy based on annualized total slope of eGFR decline over 24 months to provide confirmatory evidence of LNP023 efficacy and safety in treating patients with IgAN. The trial will enroll approximately 470 participants; 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and up to approximately 40 participants with eGFR 20 to \<30 mL/min/1.73m2 (severe renal impairment (SRI) population).

Conditions

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IgA Nephropathy

Keywords

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LNP023 IgA nephropathy IgAN, proteinuria UPCR eGFR eGFR slope kidney function decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LNP023 200mg b.i.d

Group Type EXPERIMENTAL

LNP023

Intervention Type DRUG

LNP023 200mg b.i.d

Placebo to LNP023 200mg b.i.d

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to LNP023 200mg b.i.d

Interventions

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Placebo

Placebo to LNP023 200mg b.i.d

Intervention Type DRUG

LNP023

LNP023 200mg b.i.d

Intervention Type DRUG

Other Intervention Names

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iptacopan

Eligibility Criteria

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Inclusion Criteria

* Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows:
* For patients eGFR\* ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required.
* For patients with eGFR\* 30 to \<45ml/min/1.73m2, a qualifying biopsy performed within 2 years with \< 50% tubulointerstitial fibrosis is required.
* For patients with eGFR\* 20 to \<30ml/min/1.73m2, a qualifying biopsy performed at any time.

In all cases, if a historical biopsy is not available, one may be performed during screening. \*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)

* Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline.
* Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.
* If not previously vaccinated, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration.
* All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days before first study drug administration. In addition, if patients are taking diuretics, other antihypertensive medication, or other background medication for IgAN, the doses should also be stabilized for approximately 90 days prior to the first dosing of study treatment.

Exclusion Criteria

* Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc.
* Sitting office SBP \>140 mmHg or DBP \>90 mmHg at the randomization visit
* Patients previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration.
* Prior use of iptacopan (LNP023) or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo
* History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
* Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Shanghai, , China

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Shenzhen, , China

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Medellín, Antioquia, Colombia

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sao Jose Rio Preto, , Brazil

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Oshawa, Ontario, Canada

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Temuco, , Chile

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Beijing, Beijing Municipality, China

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Beijing, Beijing Municipality, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Shenzhen, Guangdong, China

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Luoyang, Henan, China

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Zhengzhou, Henan, China

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Changsha, Hunan, China

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Changchun, Jilin, China

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Yinchuan, Ningxia, China

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Taiyuan, Shanxi, China

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Xian, Shanxi, China

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Ürümqi, Xinjiang, China

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Hangzhou, Zhejiang, China

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Ningbo, Zhejiang, China

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Wenzhou, Zhejiang, China

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Beijing, , China

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AZ Kidney Dise and Hypertension Ctr

Glendale, Arizona, United States

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AKDHC Medical Research ServicesLLC

Phoenix, Arizona, United States

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Novartis Investigative Site

Beijing, , China

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UCLA Medical Center

Los Angeles, California, United States

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Kaiser Permanente

San Diego, California, United States

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North America Research Institute

San Dimas, California, United States

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University of Colorado Anschutz

Aurora, Colorado, United States

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Nephrology Associates PA

Newark, Delaware, United States

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Boise Kidney and Hypertension

Boise, Idaho, United States

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CaRe Research

Chubbuck, Idaho, United States

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Nep Assoc of Northern Illinois

Hinsdale, Illinois, United States

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Renal Associates of Baton Rouge

Baton Rouge, Louisiana, United States

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Johns Hopkins Hospital

Baltimore, Maryland, United States

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Novartis Investigative Site

Guangzhou, , China

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Novartis Investigative Site

Ningbo, , China

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Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, United States

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University of Michigan

Ann Arbor, Michigan, United States

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Mayo Clinic Rochester

Rochester, Minnesota, United States

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Clin Rsrch Consult a JCCT Company

Kansas City, Missouri, United States

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DaVita Clinical Research

Las Vegas, Nevada, United States

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New Jersey Kidney Care

Jersey City, New Jersey, United States

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Columbia University Irving Medical

New York, New York, United States

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Dallas Renal Group

Dallas, Texas, United States

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Prolato Clinical Research Center

Houston, Texas, United States

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Univ of Washington Medi Cen

Seattle, Washington, United States

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Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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CABA, , Argentina

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CABA, , Argentina

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Santa Fe, , Argentina

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Westmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Parkville, Victoria, Australia

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St Albans, Victoria, Australia

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Roeselare, West-Vlaanderen, Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Qingdao, , China

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Shanghai, , China

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Barranquilla, Atlántico, Colombia

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Prague, , Czechia

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Aalborg, , Denmark

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Arhus N, , Denmark

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Copenhagen, , Denmark

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Odense C, , Denmark

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Göttingen, Lower Saxony, Germany

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Dresden, Saxony, Germany

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Aachen, , Germany

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Berlin, , Germany

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Essen, , Germany

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Hanover, , Germany

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Kiel, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Pécs, Baranya, Hungary

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Debrecen, Hajdu Bihar Megye, Hungary

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Szeged, , Hungary

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Bangalore, Karnataka, India

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New Delhi, National Capital Territory of Delhi, India

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New Delhi, National Capital Territory of Delhi, India

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Hyderabad, Telangana, India

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Ashkelon, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Bologna, BO, Italy

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Napoli, , Italy

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Kasugai, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Toyota, Aichi-ken, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokohama, Kanagawa-ku, Japan

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Kyoto, Kyoto, Japan

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Matsumoto, Nagano, Japan

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Osaka, Osaka, Japan

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Ōmihachiman, Shiga, Japan

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Chiba, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Kuala Lumpur, Kuala Lumpur, Malaysia

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Kuala Lumpur, , Malaysia

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Mexicali, Baja California Norte, Mexico

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Mexico City, , Mexico

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Querétaro, , Mexico

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Groningen, Provincie Groningen, Netherlands

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Nordbyhagen, Oslo County, Norway

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Bergen, , Norway

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Omsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Košice, Slovakia, Slovakia

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Maribor, Slovenia, Slovenia

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Ljubljana, , Slovenia

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Bloemfontein, Free State, South Africa

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Bundang Gu, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Cheongju-si, North Chungcheong, South Korea

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Busan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Taegu, , South Korea

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Pamplona, Navarre, Spain

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Barcelona, , Spain

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Salamanca, , Spain

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Seville, , Spain

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Danderyd, , Sweden

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Stockholm, , Sweden

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Istanbul, Fatih, Turkey (Türkiye)

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Istanbul, Fatih, Turkey (Türkiye)

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Köseköy, Kocaeli, Turkey (Türkiye)

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Antalya, Konyaalti, Turkey (Türkiye)

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Kayseri, Melikgazi, Turkey (Türkiye)

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Istanbul, Sariyer, Turkey (Türkiye)

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Istanbul, Sultangazi, Turkey (Türkiye)

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Ankara, Yenimahalle, Turkey (Türkiye)

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Mersin, Yenisehir, Turkey (Türkiye)

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Newcastle upon Tyne, Tyne and Wear, United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Salford, , United Kingdom

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Ho Chi Minh City, VNM, Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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Finland Puerto Rico United States Argentina Australia Belgium Brazil Canada Chile China Colombia Czechia Denmark France Germany Hungary India Israel Italy Japan Malaysia Mexico Netherlands Norway Russia Singapore Slovakia Slovenia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) United Kingdom Vietnam

References

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Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Reference Type DERIVED
PMID: 38299639 (View on PubMed)

Perkovic V, Barratt J, Rovin B, Kashihara N, Maes B, Zhang H, Trimarchi H, Kollins D, Papachristofi O, Jacinto-Sanders S, Merkel T, Guerard N, Renfurm R, Hach T, Rizk DV; APPLAUSE-IgAN Investigators. Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):531-543. doi: 10.1056/NEJMoa2410316. Epub 2024 Oct 25.

Reference Type DERIVED
PMID: 39453772 (View on PubMed)

Zhang H, Rizk DV, Perkovic V, Maes B, Kashihara N, Rovin B, Trimarchi H, Sprangers B, Meier M, Kollins D, Papachristofi O, Milojevic J, Junge G, Nidamarthy PK, Charney A, Barratt J. Results of a randomized double-blind placebo-controlled Phase 2 study propose iptacopan as an alternative complement pathway inhibitor for IgA nephropathy. Kidney Int. 2024 Jan;105(1):189-199. doi: 10.1016/j.kint.2023.09.027. Epub 2023 Oct 31.

Reference Type DERIVED
PMID: 37914086 (View on PubMed)

El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29.

Reference Type DERIVED
PMID: 37772889 (View on PubMed)

Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.

Reference Type DERIVED
PMID: 35675911 (View on PubMed)

Other Identifiers

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CLNP023A2301

Identifier Type: -

Identifier Source: org_study_id