NCT07156149

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
26mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

September 3, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 17, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 3, 2025

Last Update Submit

April 7, 2026

Conditions

C3 Glomerulopathy

Keywords

C3 glomerulopathyC3GFabhalta

Outcome Measures

Primary Outcomes (1)

  • Number of patients with infections

    Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period

    360 Days

Secondary Outcomes (7)

  • Incidence of adverse events and adverse reactions

    360 Days

  • Changes in UPCR

    Baseline, 360 Days

  • Changes in eGFR

    Baseline, 360 Days

  • Proportion of patients achieving the composite renal endpoint at the final assessment.

    360 Days

  • Changes in blood urea nitrogen (BUN)

    360 Days

  • +2 more secondary outcomes

Study Arms (1)

iptacopan

patients administered iptacopan in clinical practice

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who received Fabhalta.

You may qualify if:

  • All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8650, Japan

RECRUITING

Novartis Investigative Site

Toyoake, Aichi-ken, 4701192, Japan

RECRUITING

Novartis Investigative Site

Hirosaki, Aomori, 036 8563, Japan

RECRUITING

Novartis Investigative Site

Chiba, Chiba, 2608677, Japan

RECRUITING

Novartis Investigative Site

Kitakyushu, Fukuoka, 8028555, Japan

RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, 0040041, Japan

RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, 060-8604, Japan

RECRUITING

Novartis Investigative Site

Tsukuba, Ibaraki, 3058576, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Komatsu, Ishikawa-ken, 923-0961, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Tsu, Mie-ken, 514-8507, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Nagasaki, Nagasaki, 852-8501, Japan

RECRUITING

Novartis Investigative Site

Shimajiri-Gun, Okinawa, 901-1303, Japan

RECRUITING

Novartis Investigative Site

Suita, Osaka, 565-0871, Japan

RECRUITING

Novartis Investigative Site

Takatsuki, Osaka, 5698686, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Kusatsu, Shiga, 525-8585, Japan

RECRUITING

Novartis Investigative Site

Ohtsu, Shiga, 5202192, Japan

RECRUITING

Novartis Investigative Site

Shimotsuga Gun, Tochigi, 321-0293, Japan

RECRUITING

Novartis Investigative Site

Tokushima, Tokushima, 7708503, Japan

RECRUITING

Novartis Investigative Site

Bunkyo-ku, Tokyo, 1138519, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Fuchū, Tokyo, 1838561, Japan

RECRUITING

Novartis Investigative Site

Nakano City, Tokyo, 164-8607, Japan

RECRUITING

Novartis Investigative Site

Shinjuku Ku, Tokyo, 1628666, Japan

RECRUITING

Novartis Investigative Site

Yosa, Yosa, 629-2261, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Hiroshima, 734 8530, Japan

RECRUITING

Novartis Investigative Site

Nara, 630-8581, Japan

ACTIVE NOT RECRUITING

Novartis Investigative Site

Wakayama, 640-8558, Japan

ACTIVE NOT RECRUITING

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+81337978748novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 5, 2025

Study Start

September 17, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(26)