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New hope for rare kidney patients: Long-Term drug trial shows promise

NCT ID NCT03955445

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 3 times

Summary

This study looks at the long-term safety and effectiveness of a drug called iptacopan for people with two rare kidney diseases: C3 glomerulopathy and IC-MPGN. About 225 adults who have already completed a previous iptacopan study will take the drug for an extended period. The goal is to see if iptacopan can help stabilize kidney function and reduce protein in the urine over time.

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 225 people

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

Started

Oct 2019

Expected to finish

May 2036

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 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: \- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug Exclusion Criteria: * Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study * Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening. * History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects * History of HIV or any other immunodeficiency disease Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

complement 3 glomerulopathy immunoglobulin-mediated membranoproliferative glomerulonephritis membranoproliferative glomerulonephritis

As listed by the trial registrant

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

C3 glomerulopathy Immune-complex-membranoproliferative glomerulonephritis

How to take part

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

  1. The places running it

    36 sites in 13 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

  • Childrens Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Col Uni Med Center New York Presby

    RECRUITING

    New York, New York, 10032, United States

  • Georgia Nephrology Research Inst

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1425AGC, Argentina

  • Novartis Investigative Site

    RECRUITING

    Buenos Aires, W3400ABH, Argentina

  • Novartis Investigative Site

    RECRUITING

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Novartis Investigative Site

    RECRUITING

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    RECRUITING

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

  • Novartis Investigative Site

    RECRUITING

    Botucatu, São Paulo, 3880-1001, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    RECRUITING

    Salvador, 40323-010, Brazil

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200040, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Paris, 75015, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75015, France

  • Novartis Investigative Site

    RECRUITING

    Toulouse, 31054, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    RECRUITING

    Mainz, 55131, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Heraklion Crete., 715 00, Greece

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Thessaloniki, 546 42, Greece

  • Novartis Investigative Site

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    RECRUITING

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    RECRUITING

    Ranica, BG, 24020, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Asahikawa, Hokkaido, 0788510, Japan

  • Novartis Investigative Site

    COMPLETED

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Takatsuki, Osaka, 5691192, Japan

  • Novartis Investigative Site

    RECRUITING

    Ohtsu, Shiga, 5202192, Japan

  • Novartis Investigative Site

    RECRUITING

    Hachiōji, Tokyo, 193-0998, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Niigata, 9518520, Japan

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    COMPLETED

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41009, Spain

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Köseköy, Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

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

  • Novartis Investigative Site

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242-1091, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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