CHART-C3G/CLNP023B12011
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iptacopan.
- Who it may be relevant to
- Registry conditions: C3 Glomerulopathy, Complement-mediated Kidney Disease, Proteinuria. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
C3 Glomerulopathy Patient Characteristics and Treatment Response to Iptacopan in Routine Care: Analysis of Medical Charts (CHART-C3G)
Overview
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.
Detailed 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.
Interventions
- Other Iptacopan
There is no treatment allocation for NIS trials. Patients administered Iptacopan by prescription will be enrolled.
Primary outcome measures
- Demographics: Number of patients by age [Time frame: Baseline]
- Demographics: Number of patients by sex [Time frame: Baseline]
- Demographics: Number of patients by site [Time frame: Baseline]
- Demographics: Body mass index [Time frame: Baseline]
- Demographics: Number of patinets with Biopsy confirming C3G [Time frame: Baseline]
- Clinical symptoms: Proteinuria - Number of participants by 24-hour uPCR [Time frame: Baseline]
- Proteinuria - Number of participants by spot uPCR [Time frame: Baseline]
- Proteinuria, 24-hour uPCR in g/g [Time frame: Baseline]
- Proteinuria, spot uPCR in g/g [Time frame: Baseline]
- Clinical symptoms: Albuminuria [Time frame: Baseline]
Secondary outcome measures (12)
- Clinical events and outcomes: Number of participants with kindney failure during follow-up [Time frame: Up to 12 months]
- Clinical events and outcomes: Time from C3G diagnosis to kidney failure and time from baseline to kidney failure [Time frame: Up to 12 months]
- Clinical events and outcomes: Number of participants with dialysis during follow-up [Time frame: Up to 12 months]
- Clinical events and outcomes:Time from kidney failure to first dialysis (months) [Time frame: Up to 12 months]
- Clinical events and outcomes: Time from baseline to first dialysis (months) [Time frame: Up to 12 months]
- Clinical events and outcomes: Time from kidney failure to maintenance dialysis (months) [Time frame: Up to 12 months]
- Clinical events and outcomes: Time from C3G diagnosis to maintenance dialysis (months) [Time frame: Up to 12 months]
- Clinical events and outcomes: Time from baseline to maintenance dialysis (months) [Time frame: Up to 12 months]
- Clinical events and outcomes: Number of participants with complete remission (controlled) of C3G during follow-up [Time frame: Up to 12 months]
- Clinical events and outcomes: Number of participants with nephrotic-range and non-nephrotic range proteinuria during follow-up [Time frame: Up to 12 months]
- Clinical events and outcomes: Number of participants with renal relapse, progression to a higher CKD stage, or chronic renal replacement therapy during follow-up [Time frame: Up to 12 months]
- Clinical events and outcomes: Number of transplant failures per patient during follow-up [Time frame: Up to 12 months]
Eligibility criteria
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
- Interventional C3G clinical trial participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07331259 · CLNP023B12011