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New hope for kidney disease: Long-Term drug safety trial underway

NCT ID NCT04557462

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study looks at the long-term safety of a drug called iptacopan for adults with a kidney disease called primary IgA nephropathy. Participants have already completed earlier studies and will continue taking the drug to monitor side effects and see if it helps slow kidney damage over time. The goal is to keep the disease under control while collecting important safety information.

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

448 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

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: * For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period. * eGFR\* ≥ 20 ml/min/1.73m2 \*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines) * Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d. * Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations. * All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines. * participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study Exclusion Criteria: * participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason. * Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023. * Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI) * Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months. * Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out. * Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer. * History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome glomerulonephritis IgA glomerulonephritis

As listed by the trial registrant

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

Primary IgA nephropathy

Contacts and locations

Locations

  • AZ Kidney Dise and Hypertension Ctr

    Glendale, Arizona, 85306, 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

  • Col Uni Med Center New York Presby

    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

  • 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, X5016KEH, Argentina

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KET, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    CABA, C1426ABP, Argentina

  • Novartis Investigative Site

    Santa Fe, S3000EPV, Argentina

  • 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

    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

    Temuco, 4781151, Chile

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100013, China

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 102218, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, 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

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, 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

    Aarhus N, 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

    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

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Pécs, Baranya, 7623, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, 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, 4701192, Japan

  • Novartis Investigative Site

    Toyota, Aichi-ken, 471-8513, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0068555, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608604, Japan

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 213-8587, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 224-8503, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 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

    Osaka, 5308480, Japan

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Benito Juárez, 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

    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, 040 11, Slovakia

  • 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, 03312, South Korea

  • Novartis Investigative Site

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Novartis Investigative Site

    Seoul, Seoul, 03080, 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

    Stockholm, 141 86, Sweden

  • Novartis Investigative Site

    Kaohsiung City, 833, 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

    Taichung, 407219, 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, 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

    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

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    Leicester, LE5 4PW, United Kingdom

  • Novartis Investigative Site

    London, SE5 9RS, 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

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

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Other studies related to the condition(s) this trial covers.