CHART-C3G/CLNP023B12011

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Interventional C3G clinical trial participation

Trial design

Treatments tested in this trial

  • Iptacopan

Treatment groups

83 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators