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New drug iptacopan aims to protect kidneys in rare C3G disease

NCT ID NCT04817618

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether iptacopan can reduce protein in the urine and preserve kidney function in people with complement 3 glomerulopathy (C3G), a rare kidney disease. About 98 adults and adolescents will receive either iptacopan or a placebo for 6 to 12 months. The study is double-blind, meaning neither participants nor doctors know who gets the real drug.

What this could mean

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

Active substance
iptacopan (also called LNP023)
What this could lead to
If successful, iptacopan could become a new treatment option to slow kidney damage and reduce protein leakage in people with C3G.
What could go wrong
This is a Phase 3 trial, but it is still relatively small (98 participants) and results may not apply to all patients. The drug may not prove superior to 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

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jan 2027

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

12 to 60 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 participants age ≥ 12 and ≤ 60 years at screening. * Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents. * Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization. * Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening. * UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15. * Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15. * Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment. * If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. Exclusion Criteria: * Participants who have received any cell or organ transplantation, including a kidney transplantation. * Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli. * Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50% * Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care. * Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration * The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration. * A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae. * The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit. * The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration. * Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

complement 3 glomerulopathy proteinuria

As listed by the trial registrant

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

C3G

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    WITHDRAWN

    Albany, New York, 12208, United States

  • Baylor Scott and White Research

    WITHDRAWN

    Temple, Texas, 76502, United States

  • Brigham and Womens Hosp Harvard Med School

    WITHDRAWN

    Boston, Massachusetts, 02115, United States

  • Childrens Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Col Uni Med Center New York Presby

    COMPLETED

    New York, New York, 10032, United States

  • Georgia Nephrology Research Inst

    COMPLETED

    Lawrenceville, Georgia, 30046, United States

  • Hackensack Uni Medical Center

    WITHDRAWN

    Hackensack, New Jersey, 07601, United States

  • IN University School of Med

    WITHDRAWN

    Indianapolis, Indiana, 46202-5111, United States

  • Johns Hopkins Hospital

    WITHDRAWN

    Baltimore, Maryland, 21287, United States

  • Nicklaus Childrens Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Novartis Investigative Site

    WITHDRAWN

    Córdoba, Córdoba Province, X5016KET, Argentina

  • Novartis Investigative Site

    COMPLETED

    Buenos Aires, W3400ABH, Argentina

  • Novartis Investigative Site

    WITHDRAWN

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    WITHDRAWN

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    WITHDRAWN

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    RECRUITING

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    RECRUITING

    Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    Joinville, Santa Catarina, 89227-680, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    Santo André, São Paulo, 09090-790, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    São Paulo, São Paulo, 05403 000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    COMPLETED

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    COMPLETED

    Toronto, Ontario, M5G 2C4, Canada

  • Novartis Investigative Site

    WITHDRAWN

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    WITHDRAWN

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Shanghai, 200040, China

  • Novartis Investigative Site

    COMPLETED

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    COMPLETED

    Lille, 59037, France

  • Novartis Investigative Site

    WITHDRAWN

    Marseille, 13005, France

  • Novartis Investigative Site

    WITHDRAWN

    Montpellier, 34295, France

  • Novartis Investigative Site

    COMPLETED

    Paris, 75015, France

  • Novartis Investigative Site

    WITHDRAWN

    Paris, 75019, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Aachen, 52074, Germany

  • Novartis Investigative Site

    COMPLETED

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    COMPLETED

    Essen, 45147, Germany

  • Novartis Investigative Site

    COMPLETED

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Hanover, 30625, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    COMPLETED

    Mainz, 55131, Germany

  • Novartis Investigative Site

    WITHDRAWN

    Athens, 115 27, Greece

  • Novartis Investigative Site

    COMPLETED

    Heraklion Crete., 715 00, Greece

  • Novartis Investigative Site

    COMPLETED

    Thessaloniki, 546 42, Greece

  • Novartis Investigative Site

    WITHDRAWN

    Thessaloniki, 546 42, Greece

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

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

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

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

  • Novartis Investigative Site

    WITHDRAWN

    Hyderabad, Telangana, 500058, India

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Lucknow, Uttar Pradesh, 226014, India

  • Novartis Investigative Site

    WITHDRAWN

    Dehradun, Uttarakhand, 248001, India

  • Novartis Investigative Site

    COMPLETED

    Petah Tikva, 4920235, Israel

  • Novartis Investigative Site

    COMPLETED

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Ranica, BG, 24020, Italy

  • Novartis Investigative Site

    WITHDRAWN

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    COMPLETED

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    COMPLETED

    Asahikawa, Hokkaido, 0788510, Japan

  • Novartis Investigative Site

    COMPLETED

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    COMPLETED

    Takatsuki, Osaka, 5691192, Japan

  • Novartis Investigative Site

    COMPLETED

    Ohtsu, Shiga, 5202192, Japan

  • Novartis Investigative Site

    COMPLETED

    Niigata, 9518520, Japan

  • Novartis Investigative Site

    WITHDRAWN

    Nijmegen, Gelderland, 6500HB, Netherlands

  • Novartis Investigative Site

    COMPLETED

    Leiden, South Holland, 2333 ZA, Netherlands

  • Novartis Investigative Site

    WITHDRAWN

    Barcelona, Catalonia, 08025, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Port de Sagunt, Valencia, 46520, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    COMPLETED

    Madrid, 28041, Spain

  • Novartis Investigative Site

    WITHDRAWN

    Málaga, 29010, Spain

  • Novartis Investigative Site

    COMPLETED

    Seville, 41009, Spain

  • Novartis Investigative Site

    COMPLETED

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    WITHDRAWN

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    WITHDRAWN

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    WITHDRAWN

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    COMPLETED

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    COMPLETED

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    WITHDRAWN

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    WITHDRAWN

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

  • Novartis Investigative Site

    COMPLETED

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    London, WC1N 3JH, United Kingdom

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242-1091, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

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