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
This trial does not accept healthy volunteersQualifiers
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 population
Patients aged ≥18 years clinically diagnosed with C3G from participating study sites who initiate iptacopan during the period between 31-Mar-2025 and 31-Dec-2025
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Iptacopan
Other interventionThere is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: Iptacopan1 intervention
Trial outcomes
Primary outcomes
1
Demographics: Number of patients by age
Age at baseline in years
Time frame
Baseline2
Demographics: Number of patients by sex
Female Male
Time frame
Baseline3
Demographics: Number of patients by site
Academic hospital Other sites
Time frame
Baseline4
Demographics: Body mass index
Body mass index reported at baseline, or the closest value before baseline. In the absence of records for body mass index, it can be calculated using records of height and weight.
Time frame
BaselineSecondary outcomes
1
Clinical events and outcomes: Number of participants with kindney failure during follow-up
No Yes
Time frame
Up to 12 months2
Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure
Concerns only patients with kidney failure during follow-up
Time frame
Up to 12 months3
Clinical events and outcomes: Number of participants with dialysis during follow-up
No Yes Maintenance dialysis Other types
Time frame
Up to 12 months4
Clinical events and outcomes:Time from kidney failure to first dialysis (months)
Concerns only patients with dialysis during follow-up
Time frame
Up to 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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