AzTrials
AzTrials

IgA NephropathyPhase 3APPLAUSE-IgANNCT04578834

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

A Phase 3 study testing LNP023 in people with IgA Nephropathy, run by Novartis Pharmaceuticals at 177 sites in 35 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study was 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
IgA Nephropathy
What is being tested?
LNP023
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
517 participants
Where
177 sitesin 35 countries
Study dates
25 Jan 2021to 19 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

177 sites in 35 countries.

177 sites in 35 countries

China24 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100013

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 102218

  • Novartis Investigative Site

    Beijing, 100029

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Changchun, Jilin, 130041

  • Novartis Investigative Site

    Changsha, Hunan, 410011

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630

  • Novartis Investigative Site

    Guangzhou, 510080

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Luoyang, Henan, 471003

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016

  • Novartis Investigative Site

    Ningbo, 315010

  • Novartis Investigative Site

    Qingdao, 266000

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shanghai, 200040

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518000

  • Novartis Investigative Site

    Shenzhen, 518036

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

  • Novartis Investigative Site

    Xian, Shanxi, 710061

  • Novartis Investigative Site

    Yinchuan, Ningxia, 750004

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003

Other trials in China

United States22 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado Anschutz

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Boise Kidney and Hypertension

    Boise, Idaho, 83706

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts, 02115

  • CaRe Research

    Chubbuck, Idaho, 83202

  • Dallas Renal Group

    Dallas, Texas, 75230

  • AZ Kidney Dise and Hypertension Ctr

    Glendale, Arizona, 85306

  • Nep Assoc of Northern Illinois

    Hinsdale, Illinois, 60521

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • New Jersey Kidney Care

    Jersey City, New Jersey, 07305

  • Clin Rsrch Consult a JCCT Company

    Kansas City, Missouri, 64112

  • DaVita Clinical Research

    Las Vegas, Nevada, 89146

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Columbia University Irving Medical

    New York, New York, 10032

  • Nephrology Associates PA

    Newark, Delaware, 19713

  • AKDHC Medical Research ServicesLLC

    Phoenix, Arizona, 85016

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Kaiser Permanente

    San Diego, California, 92111

  • North America Research Institute

    San Dimas, California, 91773

  • Univ of Washington Medi Cen

    Seattle, Washington, 98104

Other trials in United States

Japan16 sites

  • Novartis Investigative Site

    Chiba, 2608712

  • Novartis Investigative Site

    Kasugai, Aichi-ken, 4868510

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 2138587

  • Novartis Investigative Site

    Kyoto, Kyoto, 6050981

  • Novartis Investigative Site

    Matsumoto, Nagano, 3908621

  • Novartis Investigative Site

    Niigata, 9518520

  • Novartis Investigative Site

    Okayama, 7008558

  • Novartis Investigative Site

    Ōmihachiman, Shiga, 5230082

  • Novartis Investigative Site

    Osaka, Osaka, 5340021

  • Novartis Investigative Site

    Osaka, 5300012

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0068555

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608604

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 4701192

  • Novartis Investigative Site

    Toyota, Aichi-ken, 4718513

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2248503

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2360004

Other trials in Japan

Germany13 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

South Korea11 sites

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Busan, 47392

  • Novartis Investigative Site

    Cheongju-si, North Chungcheong, 28644

  • Novartis Investigative Site

    Seoul, Korea, 02841

  • Novartis Investigative Site

    Seoul, Korea, 03312

  • Novartis Investigative Site

    Seoul, Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 05278

  • Novartis Investigative Site

    Seoul, 06591

  • Novartis Investigative Site

    Seoul, 06973

  • Novartis Investigative Site

    Taegu, 41944

Other trials in South Korea

Turkey (Türkiye)9 sites

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500

  • Novartis Investigative Site

    Antalya, Konyaalti, 07070

  • Novartis Investigative Site

    Istanbul, Fatih, 34093

  • Novartis Investigative Site

    Istanbul, Fatih, 34098

  • Novartis Investigative Site

    Istanbul, Sariyer, 34396

  • Novartis Investigative Site

    Istanbul, Sultangazi, 34265

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039

  • Novartis Investigative Site

    Köseköy, Kocaeli, 41380

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110

Other trials in Turkey (Türkiye)

Brazil6 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221

  • Novartis Investigative Site

    Curitiba, Paraná, 80440-020

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Taiwan6 sites

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    New Taipei City, 22060

  • Novartis Investigative Site

    New Taipei City, 23561

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Argentina5 sites

  • Novartis Investigative Site

    CABA, C1181ACH

  • Novartis Investigative Site

    CABA, C1426ABP

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016JDA

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH

  • Novartis Investigative Site

    Santa Fe, S3000EPV

Other trials in Argentina

Australia5 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Parkville, Victoria, 3065

  • Novartis Investigative Site

    St Albans, Victoria, 3021

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom5 sites

  • Novartis Investigative Site

    Leicester, LE5 4PW

  • Novartis Investigative Site

    London, SE5 9RS

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Novartis Investigative Site

    Salford, M6 8HD

Other trials in United Kingdom

Denmark4 sites

  • Novartis Investigative Site

    Aalborg, 9000

  • Novartis Investigative Site

    Arhus N, 8200

  • Novartis Investigative Site

    Copenhagen, 2100

  • Novartis Investigative Site

    Odense C, 5000

Other trials in Denmark

India4 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

Other trials in India

Spain4 sites

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Seville, 41013

Other trials in Spain

Belgium3 sites

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Roeselare, West Vlaanderen, 8800

Other trials in Belgium

France3 sites

  • Novartis Investigative Site

    Marseille, 13005

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Paris, 75015

Other trials in France

Hungary3 sites

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Pécs, Baranya, 7623

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Israel3 sites

  • Novartis Investigative Site

    Ashkelon, 7830604

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Petah Tikva, 4941492

Other trials in Israel

Mexico3 sites

  • Novartis Investigative Site

    Benito Juárez, Mexico City, 03100

  • Novartis Investigative Site

    Mexicali, Baja California Norte, 21200

  • Novartis Investigative Site

    Querétaro, 76000

Other trials in Mexico

Russia3 sites

  • Novartis Investigative Site

    Omsk, 644112

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Saint Petersburg, 197110

Other trials in Russia

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

Colombia2 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020

  • Novartis Investigative Site

    Medellín, Antioquia, 050001

Other trials in Colombia

Italy2 sites

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Naples, 80131

Other trials in Italy

Malaysia2 sites

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Norway2 sites

  • Novartis Investigative Site

    Bergen, NO-5021

  • Novartis Investigative Site

    Nordbyhagen, Oslo, 1478

Other trials in Norway

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169608

Other trials in Singapore

Slovenia2 sites

  • Novartis Investigative Site

    Ljubljana, 1000

  • Novartis Investigative Site

    Maribor, Slovenia, 2000

Other trials in Slovenia

Sweden2 sites

  • Novartis Investigative Site

    Danderyd, 182 88

  • Novartis Investigative Site

    Stockholm, 141 86

Other trials in Sweden

Vietnam2 sites

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

Canada1 site

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9

Other trials in Canada

Chile1 site

  • Novartis Investigative Site

    Temuco, 4781151

Other trials in Chile

Czechia1 site

  • Novartis Investigative Site

    Prague, 128 08

Other trials in Czechia

Netherlands1 site

  • Novartis Investigative Site

    Groningen, Provincie Groningen, 9713 GZ

Other trials in Netherlands

Slovakia1 site

  • Novartis Investigative Site

    Košice, 040 11

Other trials in Slovakia

South Africa1 site

  • Novartis Investigative Site

    Bloemfontein, Free State, 9301

Other trials in South Africa

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

The study was 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.

Read the detailed description

The purpose of the study was to evaluate the efficacy and safety of iptacopan (LNP023) compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. This study served as the pivotal trial supporting the registration of iptacopan in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in in eGFR slope decline and reduction in proteinuria. The trial continued 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 planned to 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
IgA Nephropathy
Being tested
Placebo, LNP023
Keywords
LNP023, IgA nephropathy, IgAN, proteinuria, UPCR, eGFR, eGFR slope, kidney function decline
Medical subject headings
Glomerulonephritis, IGA, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo to LNP023 200mg b.i.d

  • LNP023Drug

    Also called iptacopan

    LNP023 200mg b.i.d

Study groups in NCT04578834
Study groupRoleWhat they receive
LNP023 200mg b.i.dExperimentalNot described
Receives: Drug: LNP023
Placebo to LNP023 200mg b.i.dPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ratio to Baseline in UPCR at 9 Months - Interim Analysis

    Evaluated at interim analysis - Ratio to baseline in Urine Protein to Creatinine Ratio (UPCR), sampled from 24h urine collection, at 9 months.

    Ratio being: UPCR at 9 months in g/g divided by UPCR at Baseline in g/g. Lower values correspond to better outcomes.

    Measured: Baseline and 9 months

  2. Annualized Total eGFR Slope Estimated Over 24 Months - Final Analysis

    Evaluated at final analysis - Annualized total eGFR slope over 24 months, expressed as the rate of change in estimated glomerular filtration rate (eGFR). eGFR is a measure of kidney function and was calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula. A negative slope indicates declining kidney function. A less negative slope indicates a slower decline in kidney function and therefore a more favorable outcome.

    Measured: 24 months

Secondary outcomes (12)

  1. Change From Baseline in eGFR at 9 Months - Interim Analysis

    Evaluated at interim analysis - Change from baseline in estimated glomerular filtration rate (eGFR) at 9 months

    Measured: Baseline and 9 months

  2. Proportion of Participants Reaching Proteinuria < 1 g/g of UPCR 24h at 9 Months - Interim Analysis

    Evaluated at interim analysis - Proportion of participants reaching proteinuria < 1 g/g of Urine Protein-To-Creatinine Ratio (UPCR) sampled from 24-hour urine collection at 9 months, without receiving Corticosteroids/Immunosuppressant (CS/IS) or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating Kidney Replacement Therapy (KRT). Marginal proportion can be interpreted as the population average probability of being a responder in each treatment group.

    Measured: Baseline and 9 months

  3. Annualized Total eGFR Slope Estimated Over 12 Months - Interim Analysis

    Evaluated at interim analysis -Annualized total eGFR slope over 12 months, expressed as the rate of change in estimated glomerular filtration rate (eGFR). eGFR is a measure of kidney function. A negative slope indicates declining kidney function. A less negative slope indicates a slower decline in kidney function and therefore a more favorable outcome.

    Measured: 12 months

  4. Change From Baseline in the FACIT-Fatigue Total Score to 9 Months - Interim Analysis

    Evaluated at interim analysis -Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue scale (version 4), is a 13-item questionnaire that assesses patient-perceived tiredness, weakness and difficulty conducting activities due to fatigue. The purpose of FACIT-Fatigue in this study was to assess the experience and impact of fatigue on participants with IgAN.

    Score ranges from 0 to 52, with higher scores indicating less fatigue.

    Measured: Baseline and 9 months

  5. Number of Participants With Adverse Events in the Main Study Population During the On-treatment Period - Interim Analysis

    Number of participants with treatment-emergent Adverse Events, including clinically significant abnormal safety laboratory parameters and vital signs during the on-treatment period.

    The on-treatment period lasts from the date of first administration of study treatment to 7 days after the date of the last actual administration of any study treatment

    Measured: Up to 24 months

  6. Number of Participants With Adverse Events in the SRI Population During the On-treatment Period - Interim Analysis

    Number of participants with treatment-emergent Adverse Events, including clinically significant abnormal safety laboratory parameters and vital signs during the on-treatment period.

    The on-treatment period lasts from the date of first administration of study treatment to 7 days after the date of the last actual administration of any study treatment

    Measured: Up to 24 months

  7. Ratio to Baseline in UPCR at 9 Months - Final Analysis

    Evaluated at final analysis - Ratio to baseline in Urine Protein to Creatinine Ratio (UPCR), sampled from 24h urine collection, at 9 months.

    Ratio being: UPCR at 9 months in g/g divided by UPCR at Baseline in g/g. Lower values correspond to better outcomes.

    In line with the testing strategy, this endpoint was not tested at the final analysis.

    Measured: Baseline and 9 months

  8. Proportion of Participants Reaching Proteinuria < 1 g/g of UPCR 24h at 9 Months - Final Analysis

    Evaluated at final analysis - Proportion of participants reaching proteinuria < 1 g/g of Urine Protein-To-Creatinine Ratio (UPCR) 24h at 9 months, without receiving Corticosteroids/Immunosuppressant (CS/IS) or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating Kidney Replacement Therapy (KRT). Marginal proportion can be interpreted as the population average probability of being a responder in each treatment group.

    Measured: Baseline and 9 months

  9. Time to First Occurrence of Composite Kidney Failure Endpoint Event - Final Analysis

    Evaluated at final analysis - Time to first occurrence of composite kidney failure endpoint, defined as a sustained decline in the eGFR of at least 30% from baseline for at least 4 weeks, a sustained eGFR of less than 15 mL/min/1.73m2 for at least 4 weeks, initiation of maintenance dialysis (defined as dialysis for a period of ≥4 weeks) or death from kidney failure.

    For clarity: Please note that the number of patients with a composite kidney failure endpoint event is presented with statistical analysis of the time to composite kidney failure endpoint event.

    Measured: Up to 24 months

  10. Change From Baseline in the FACIT-Fatigue Total Score to 9 Months - Final Analysis

    Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue scale (version 4), is a 13-item questionnaire that assesses patient-perceived tiredness, weakness and difficulty conducting activities due to fatigue. The purpose of FACIT-Fatigue in this study was to assess the experience and impact of fatigue on participants with IgAN.

    Score ranges from 0 to 52, with higher scores indicating less fatigue.

    Measured: Baseline and Month 9

  11. Number of Participants With Adverse Events in the Main Study Population During the On-treatment Period - Final Analysis

    Number of participants with treatment-emergent Adverse Events, including clinically significant abnormal safety laboratory parameters and vital signs during the on-treatment period.

    The on-treatment period lasts from the date of first administration of study treatment to 7 days after the date of the last actual administration of any study treatment

    Measured: Up to 24 months

  12. Number of Participants With Adverse Events in the SRI Population During the On-treatment Period- Final Analysis

    Number of participants with treatment-emergent Adverse Events, including clinically significant abnormal safety laboratory parameters and vital signs during the on-treatment period.

    The on-treatment period lasts from the date of first administration of study treatment to 7 days after the date of the last actual administration of any study treatment

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start25 Jan 2021
  3. Primary completion19 Sep 2025
  4. Study completion19 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04578834
Sponsor's protocol ID
CLNP023A2301
Other IDs
2024-511067-29-00
Acronym
APPLAUSE-IgAN
Status last verified
Oct 2026
First submitted
9 Sep 2020
Last updated
4 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Rovin BH, Trimarchi H, Maes B, Perkovic V, Kashihara N, Zhang H, Barratt J, Cheng H, Lee H, Lee SH, Lim SK, Raju SB, Satirapoj B, Seyahi N, Tian YC, Wu CH, Xiong ZY, Xue H, Yee SY, Petrovic-Bulatovic K, Attari Z, Butylin D, Jacinto-Sanders S, Pletscher M, Magirr A, Renfurm R, Hach T, Rizk DV. Long-term efficacy and safety for the complement factor B inhibitor iptacopan in IgA nephropathy. Kidney Int. 2026 Oct 22:S0085-2538(26)00826-4. doi: 10.1016/j.kint.2026.09.017. Online ahead of print.

    PubMed 42909451

  • Barratt J, Eren N, Kashihara N, Maes B, Rizk DV, Rovin B, Trimarchi H, Zhang H, Wang W, Kocyigit I, Hao C, Tesar V, Turgutalp K, Yang L, Xing G, Duro Garcia V, Han SH, Lu W, Pisani A, Weinmann-Menke J, Eitner F, Guerard N, Butylin D, Monaco L, Scosyrev E, Magirr A, Renfurm R, Hach T, Perkovic V; APPLAUSE-IgAN Study Group. Iptacopan in IgA Nephropathy - Final 24-Month Data. N Engl J Med. 2026 Jul 30;395(5):465-477. doi: 10.1056/NEJMoa2600743. Epub 2026 Mar 29.

    PubMed 41910396

  • Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.

    PubMed 41661687

  • 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.

    PubMed 39453772

  • 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.

    PubMed 38299639

  • 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.

    PubMed 37914086

  • 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.

    PubMed 37772889

  • 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.

    PubMed 35675911

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LNP023 in people with IgA Nephropathy, run by Novartis Pharmaceuticals at 177 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in China, United States, Japan, Germany, South Korea and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio to Baseline in UPCR at 9 Months - Interim Analysis (time frame: Baseline and 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578834, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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