CHART-C3G/CLNP023B12011

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up.

Iptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers/ centers of excellence in glomerular diseases in Germany.

The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted

NCT03832114

Glomerulonephritis

COMPLETED PHASE2

Controlled Trial Evaluating Avacopan in C3 Glomerulopathy

NCT03301467

C3 Glomerulopathy (C3G)

COMPLETED PHASE2

A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN

NCT03124368

C3 Glomerulonephritis Dense Deposit Disease C3 Glomerulopathy +2 more

COMPLETED PHASE2

C3G/Primary IC-MPGN EAP

NCT04729062

C3G IC-MPGN C3 Glomerulopathy +9 more

APPROVED_FOR_MARKETING

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

NCT04578834

IgA Nephropathy

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Until recently, there are no approved disease-specific treatments for C3G, although there is significant interest in the therapeutic potential of complement inhibition.

Iptacopan, the first oral effective targeted disease-modifying proximal complement inhibitor developed by Novartis, has been approved in April 2025 for the treatment of adults with C3G.

The primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.

By analyzing key endpoints such as age, sex, ethnicity, BMI, clinical symptoms, proteinuria, blood pressure, serum creatinine, eGFR, serum C3 levels, and renal histological parameters, we aim to better understand disease progression and treatment outcomes.

Additionally, we will assess CKD stages, history of kidney failure, dialysis status, transplant status, and comorbidities to identify the characteristics of patients treated with iptacopan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

C3 Glomerulopathy Complement-mediated Kidney Disease Proteinuria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iptacopan

Adult patients with C3G initiating iptacopan treatment in routine care

Iptacopan

Intervention Type OTHER

There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iptacopan

There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LNP023B

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of C3G (confirmed by biopsy, only if available)
* Aged ≥18 years at time of index date.
* At least 6 months of baseline period preceding index date.
* Users of iptacopan treatment including those who have discontinued iptacopan within the last twelve weeks.