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New drug fabhalta tracked in kidney disease patients

NCT ID NCT07156149

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study will follow 50 people with C3 glomerulopathy, a rare kidney disease, who are taking the drug Fabhalta. Researchers want to see how safe the drug is and how well it works in everyday clinical settings. They will track infections, side effects, and kidney function over time.

What this could mean

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

Active substance
Fabhalta (iptacopan)
What this could lead to
If successful, this could confirm that Fabhalta is a safe and effective treatment option for managing C3 glomerulopathy in everyday medical practice.
What could go wrong
This is an observational study with no control group, so results may not prove cause and effect. The small size (50 patients) limits how broadly findings can be applied.

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.

Participants

33 people

The number who actually took part.

Started

Sep 2025

Expected to finish

Jun 2028

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.

Who is studied

All patients who received Fabhalta.

Ages

0 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: * All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant). Exclusion Criteria: * Use of iptacopan for an indication not yet approved under the Clinical Trials Act or GCP (e.g., patient-requested medical treatment, investigator-initiated clinical trial)

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Conditions

The condition(s) this trial relates to.

complement 3 glomerulopathy

As listed by the trial registrant

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

C3 glomerulopathy

Contacts and locations

Locations

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466-8650, Japan

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 4701192, Japan

  • Novartis Investigative Site

    Hirosaki, Aomori, 0368563, Japan

  • Novartis Investigative Site

    Chiba, Chiba, 2608677, Japan

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 810-8563, Japan

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8028555, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0040041, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608604, Japan

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 3058576, Japan

  • Novartis Investigative Site

    Komatsu, Ishikawa-ken, 923-0961, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 231-8682, Japan

  • Novartis Investigative Site

    Tosa-gun, Kyoto, 629-2261, Japan

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-8507, Japan

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8501, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565-0871, Japan

  • Novartis Investigative Site

    Takatsuki, Osaka, 5698686, Japan

  • Novartis Investigative Site

    Kusatsu, Shiga, 525-8585, Japan

  • Novartis Investigative Site

    Ohtsu, Shiga, 5202192, Japan

  • Novartis Investigative Site

    Shizuoka, Shizuoka, 420-8527, Japan

  • Novartis Investigative Site

    Shimotsuga Gun, Tochigi, 3210293, Japan

  • Novartis Investigative Site

    Tokushima, Tokushima, 7708503, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    Fuchū, Tokyo, 1838561, Japan

  • Novartis Investigative Site

    Nakano City, Tokyo, 164-8607, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 1628666, Japan

  • Novartis Investigative Site

    Hiroshima, 7348530, Japan

  • Novartis Investigative Site

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    Nara, 630-8581, Japan

  • Novartis Investigative Site

    Wakayama, 640-8558, Japan

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