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New hope for rare kidney disease: iptacopan trial aims to protect kidneys

NCT ID NCT05755386

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tests a drug called iptacopan in people with a rare kidney disease (IC-MPGN). About 106 adults and teens will receive either iptacopan or a placebo. The main goal is to see if iptacopan reduces protein in the urine and helps preserve kidney function over 18 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
What this could lead to
If successful, iptacopan could become a new treatment option to control IC-MPGN, reducing protein leakage and slowing kidney damage.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

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 106 people

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

Started

Oct 2023

Expected to finish

May 2029

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 patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening). * Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only). * Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization * UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15 * Estimated GFR (using the chronic kidney disease \[CKD\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 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 infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care. * 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. Exclusion Criteria: * Participants who have undergone cell or solid organ transplantation, including kidney transplantation. * Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions: * Deposition of antigen-antibody immune complexes as a result of any chronic infections, including * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV); * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections * Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis Renal deposition of immune complexes as a result of a systemic autoimmune disease: * Systemic lupus erythematosus (SLE) * Sjögren syndrome * Rheumatoid arthritis * Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care. Fibrillary glomerulonephritis * Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy. * Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%. * Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or 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., Neisseria meningitidis and Streptococcus pneumoniae. * The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit. * The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration. * The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement. * Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator. * Body mass index (BMI) \>38 kg/m2 at screening and randomization. Body weight \<35 kg at screening and randomization

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Conditions

The condition(s) this trial relates to.

immunoglobulin-mediated membranoproliferative glomerulonephritis proteinuria

As listed by the trial registrant

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

Ic-MPGN

How to take part

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

  1. The places running it

    125 sites in 23 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

  • Baylor Scott and White Research

    RECRUITING

    Temple, Texas, 76502, United States

  • Boston Univ School of Medicine

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Childrens Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Col Uni Med Center New York Presby

    RECRUITING

    New York, New York, 10032, United States

  • Emory University School of Medicine-Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • MUSC Health Lancaster Med Ctr

    RECRUITING

    Lancaster, South Carolina, 29720, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Nicklaus Childrens Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1425AGC, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1425EFD, Argentina

  • Novartis Investigative Site

    RECRUITING

    Córdoba, Córdoba Province, X5000, Argentina

  • Novartis Investigative Site

    RECRUITING

    Buenos Aires, W3400ABH, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    RECRUITING

    Santa Fe, S3000EPV, Argentina

  • Novartis Investigative Site

    RECRUITING

    Fortaleza, Ceará, 60430 370, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    Brasília, Federal District, 71635-580, Brazil

  • Novartis Investigative Site

    RECRUITING

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    RECRUITING

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    Niterói, Rio de Janeiro, 24020 096, Brazil

  • Novartis Investigative Site

    WITHDRAWN

    Rio de Janeiro, Rio de Janeiro, 22211-230, Brazil

  • Novartis Investigative Site

    RECRUITING

    Natal, Rio Grande do Norte, 59012 300, Brazil

  • Novartis Investigative Site

    RECRUITING

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

  • Novartis Investigative Site

    RECRUITING

    Botucatu, São Paulo, 18618-970, Brazil

  • Novartis Investigative Site

    RECRUITING

    Santo André, São Paulo, 09090-790, Brazil

  • Novartis Investigative Site

    RECRUITING

    Sao Jose Rio Preto, São Paulo, 15090-000, 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

    São Paulo, São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    RECRUITING

    Etobicoke, Ontario, M9W 6V1, Canada

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    RECRUITING

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • Novartis Investigative Site

    RECRUITING

    Marseille, 13005, France

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75015, France

  • Novartis Investigative Site

    RECRUITING

    Rennes, 35033, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31054, France

  • Novartis Investigative Site

    RECRUITING

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    RECRUITING

    Hanover, 30625, Germany

  • Novartis Investigative Site

    RECRUITING

    Mainz, 55131, Germany

  • Novartis Investigative Site

    RECRUITING

    Ulm, 89081, Germany

  • Novartis Investigative Site

    RECRUITING

    Athens, 115 27, Greece

  • Novartis Investigative Site

    RECRUITING

    Chaïdári, 124 62, Greece

  • Novartis Investigative Site

    RECRUITING

    Heraklion Crete., 715 00, Greece

  • Novartis Investigative Site

    RECRUITING

    Ioannina, 455 00, Greece

  • Novartis Investigative Site

    RECRUITING

    Pátrai, 265 04, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 54636, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 570 10, Greece

  • Novartis Investigative Site

    RECRUITING

    Bangalore, Karnataka, 560004, India

  • Novartis Investigative Site

    RECRUITING

    Nagpur, Maharashtra, 440015, India

  • Novartis Investigative Site

    RECRUITING

    Pune, Maharashtra, 411011, India

  • Novartis Investigative Site

    RECRUITING

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

  • Novartis Investigative Site

    RECRUITING

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Jerusalem, 9103102, Israel

  • Novartis Investigative Site

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Novartis Investigative Site

    RECRUITING

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    RECRUITING

    Ranica, BG, 24020, Italy

  • Novartis Investigative Site

    RECRUITING

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    RECRUITING

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    RECRUITING

    Naples, 80131, Italy

  • Novartis Investigative Site

    RECRUITING

    Toyoake, Aichi-ken, 4701192, Japan

  • Novartis Investigative Site

    RECRUITING

    Fuchū, Tokyo, 1838561, Japan

  • Novartis Investigative Site

    RECRUITING

    Hachiōji, Tokyo, 193-0998, Japan

  • Novartis Investigative Site

    RECRUITING

    Okayama, 7008558, Japan

  • Novartis Investigative Site

    RECRUITING

    Osaka, 558-8558, Japan

  • Novartis Investigative Site

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Novartis Investigative Site

    RECRUITING

    Bialystok, 15-540, Poland

  • Novartis Investigative Site

    RECRUITING

    Krakow, 30-688, Poland

  • Novartis Investigative Site

    RECRUITING

    Olsztyn, 10-561, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 02-006, Poland

  • Novartis Investigative Site

    RECRUITING

    Warsaw, 02-097, Poland

  • Novartis Investigative Site

    WITHDRAWN

    Wroclaw, 50-417, Poland

  • Novartis Investigative Site

    RECRUITING

    Martin, Slovakia, 036 59, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Banská Bystrica, 975 17, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Košice, 041 90, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    RECRUITING

    Almería, 04009, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 280796, Spain

  • Novartis Investigative Site

    RECRUITING

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    WITHDRAWN

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 81346, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Izmir, Karsiyaka, 35575, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Köseköy, Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Mersin, Yenisehir, 33110, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Salford, M6 8HD, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Ho Chi Minh City, 700000, Vietnam

  • OHSU Dept of Nephrology

    RECRUITING

    Portland, Oregon, 97239, United States

  • Olive View UCLA Medical Center

    RECRUITING

    Sylmar, California, 91342, United States

  • Prolato Clinical Research Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94115, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • Univ Cali Irvine ALS Neuromuscular

    RECRUITING

    Orange, California, 92868, United States

  • Univ of Pennsylvania Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University Of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131-0001, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Washington University in St Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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