CHART-C3G/CLNP023B12011

Novartis

Status

Not yet enrolling

Conditions

Proteinuria

C3 Glomerulopathy

Complement-mediated Kidney Disease

Treatments

Other: Iptacopan

Study type

Observational

Funder types

Industry

Identifiers

NCT07331259

CLNP023B12011

Details and patient eligibility

About

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.

Full description

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.

Enrollment

83 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria