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New drug shows promise in slowing kidney disease

NCT ID NCT04578834

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested iptacopan (LNP023) in 518 adults with IgA nephropathy, a kidney disease that can lead to kidney failure. Participants received either the drug or a placebo, on top of standard care. The goal was to see if iptacopan reduces protein in the urine and slows the decline of kidney function over 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iptacopan (LNP023)
What this could lead to
If successful, iptacopan could offer a new treatment option to slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
What could go wrong
This is a phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

518 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IgA nephropathy

Contacts and locations

Locations

  • AKDHC Medical Research ServicesLLC

    Phoenix, Arizona, 85016, United States

  • AZ Kidney Dise and Hypertension Ctr

    Glendale, Arizona, 85306, United States

  • Boise Kidney and Hypertension

    Boise, Idaho, 83706, United States

  • Brigham and Womens Hosp Harvard Med School

    Boston, Massachusetts, 02115, United States

  • CaRe Research

    Chubbuck, Idaho, 83202, United States

  • Clin Rsrch Consult a JCCT Company

    Kansas City, Missouri, 64111, United States

  • Columbia University Irving Medical

    New York, New York, 10032, United States

  • DaVita Clinical Research

    Las Vegas, Nevada, 89146, United States

  • Dallas Renal Group

    Dallas, Texas, 75230, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente

    San Diego, California, 92111, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Nep Assoc of Northern Illinois

    Hinsdale, Illinois, 60521, United States

  • Nephrology Associates PA

    Newark, Delaware, 19713, United States

  • New Jersey Kidney Care

    Jersey City, New Jersey, 07305, United States

  • North America Research Institute

    San Dimas, California, 91773, United States

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016JDA, Argentina

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    CABA, C1426ABP, Argentina

  • Novartis Investigative Site

    Santa Fe, S3000EPV, Argentina

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Parkville, Victoria, 3065, Australia

  • Novartis Investigative Site

    St Albans, Victoria, 3021, Australia

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    Curitiba, Paraná, 80440-020, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000, Brazil

  • Novartis Investigative Site

    Sao Jose Rio Preto, 15090 000, Brazil

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9, Canada

  • Novartis Investigative Site

    Temuco, 4781151, Chile

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100013, China

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 102218, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510030, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518000, China

  • Novartis Investigative Site

    Luoyang, Henan, 471003, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    Changsha, Hunan, 410011, China

  • Novartis Investigative Site

    Changchun, Jilin, 130041, China

  • Novartis Investigative Site

    Yinchuan, Ningxia, 750004, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    Beijing, 100029, China

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Guangzhou, 510080, China

  • Novartis Investigative Site

    Ningbo, 315010, China

  • Novartis Investigative Site

    Qingdao, 266000, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Shenzhen, 518036, China

  • Novartis Investigative Site

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080020, Colombia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Aalborg, 9000, Denmark

  • Novartis Investigative Site

    Arhus N, DK-8200, Denmark

  • Novartis Investigative Site

    Copenhagen, DK-2100, Denmark

  • Novartis Investigative Site

    Odense C, 5000, Denmark

  • Novartis Investigative Site

    Marseille, 13005, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Magdeburg, 39120, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Pécs, Baranya, 7623, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    Ashkelon, 7830604, Israel

  • Novartis Investigative Site

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Kasugai, Aichi-ken, 486-8510, Japan

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 470 1192, Japan

  • Novartis Investigative Site

    Toyota, Aichi-ken, 471-8513, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8604, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 68555, Japan

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 213-8587, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 224-8503, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa-ku, 236-0004, Japan

  • Novartis Investigative Site

    Kyoto, Kyoto, 605-0981, Japan

  • Novartis Investigative Site

    Matsumoto, Nagano, 3908621, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    Ōmihachiman, Shiga, 523-0082, Japan

  • Novartis Investigative Site

    Chiba, 2608712, Japan

  • Novartis Investigative Site

    Niigata, 9518520, Japan

  • Novartis Investigative Site

    Okayama, 7008558, Japan

  • Novartis Investigative Site

    Osaka, 5300012, Japan

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Mexicali, Baja California Norte, 21200, Mexico

  • Novartis Investigative Site

    Mexico City, 03100, Mexico

  • Novartis Investigative Site

    Querétaro, 76000, Mexico

  • Novartis Investigative Site

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Nordbyhagen, Oslo, 1478, Norway

  • Novartis Investigative Site

    Bergen, NO-5021, Norway

  • Novartis Investigative Site

    Omsk, 644112, Russia

  • Novartis Investigative Site

    Rostov-on-Don, 344022, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197110, Russia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Košice, Slovakia, 040 11, Slovakia

  • Novartis Investigative Site

    Maribor, Slovenia, 2000, Slovenia

  • Novartis Investigative Site

    Ljubljana, 1000, Slovenia

  • Novartis Investigative Site

    Bloemfontein, Free State, 9301, South Africa

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 02841, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 03080, South Korea

  • Novartis Investigative Site

    Seoul, Korea, 03312, South Korea

  • Novartis Investigative Site

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Novartis Investigative Site

    Busan, 47392, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Seoul, 06973, South Korea

  • Novartis Investigative Site

    Seoul, 134 727, South Korea

  • Novartis Investigative Site

    Taegu, 41944, South Korea

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Danderyd, 182 88, Sweden

  • Novartis Investigative Site

    Stockholm, 141 86, Sweden

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    New Taipei City, 22060, Taiwan

  • Novartis Investigative Site

    New Taipei City, 23561, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Köseköy, Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    Antalya, Konyaalti, 07070, Turkey (Türkiye)

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Sariyer, 34396, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Sultangazi, 34265, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110, Turkey (Türkiye)

  • Novartis Investigative Site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • Novartis Investigative Site

    Leicester, LE5 4PW, United Kingdom

  • Novartis Investigative Site

    London, SE5 9RS, United Kingdom

  • Novartis Investigative Site

    London, SW17 0QT, United Kingdom

  • Novartis Investigative Site

    Salford, M6 8HD, United Kingdom

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 700000, Vietnam

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 80808, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Univ of Washington Medi Cen

    Seattle, Washington, 98104, United States

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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