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.
Age range
18 Years – 100 Years
Sex
ALL
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Demographics: Number of patients by age
Timeframe: Baseline
Demographics: Number of patients by sex
Timeframe: Baseline
Demographics: Number of patients by site
Timeframe: Baseline
Demographics: Body mass index
Timeframe: Baseline
Demographics: Number of patinets with Biopsy confirming C3G
Timeframe: Baseline
Clinical symptoms: Proteinuria - Number of participants by 24-hour uPCR
Timeframe: Baseline
Proteinuria - Number of participants by spot uPCR
Timeframe: Baseline
Proteinuria, 24-hour uPCR in g/g
Timeframe: Baseline
Proteinuria, spot uPCR in g/g
Timeframe: Baseline
Clinical symptoms: Albuminuria
Timeframe: Baseline
Albuminuria - Number of participants by spot uACR
Timeframe: Baseline
Albuminuria, 24-hour uACR in g/g
Timeframe: Baseline
Albuminuria, spot uACR in g/g
Timeframe: Baseline
Clinical symptoms: Number of participants by Hematuria - dipstick results
Timeframe: Baseline
Hematuria - Number of participants by urinalysis results
Timeframe: Baseline
Hematuria - urinalysis, number of red blood cells
Timeframe: Baseline
Clinical symptoms: Number of participants with presence of edema
Timeframe: Baseline
Clinical symptoms: Systolic and diastolic blood pressure
Timeframe: Baseline
Clinical symptoms: Number of participants with hypertension
Timeframe: Baseline
Clinical symptoms: Serum creatinine at baseline
Timeframe: Baseline
Clinical symptoms: Reported eGFR at baseline
Timeframe: Baseline
Clinical symptoms: Number of participants by equation used in reported eGFR at baseline
Timeframe: Baseline
Clinical symptoms: Computed eGFR at baseline
Timeframe: Baseline
Clinical symptoms: Serum C3 at baseline
Timeframe: Baseline
Clinical events and outcomes: Time since C3G diagnosis (days/months)
Timeframe: Baseline
Clinical events and outcomes: Number of participants with Chronic Kidney Disease (CKD) and stage
Timeframe: Baseline
Clinical events and outcomes: Number of participants with history of kidney failure
Timeframe: Baseline
Clinical events and outcomes: Number of participants by dialysis status
Timeframe: Baseline
Clinical events and outcomes: Time from C3G diagnosis to dialysis (months)
Timeframe: Baseline
Clinical events and outcomes: Time from dialysis to baseline (months)
Timeframe: Baseline
Clinical events and outcomes: Number of participants by transplant status at baseline
Timeframe: Baseline
Clinical events and outcomes: Time from C3G diagnosis to kidney transplant before baseline (months)
Timeframe: Baseline
Clinical events and outcomes: Time from kidney transplant before baseline to baseline (months)
Timeframe: Baseline
Clinical events and outcomes: Number of participants with C3G disease recurrence post-transplant and/or transplant failure
Timeframe: Baseline
Clinical events and outcomes: Number of participants with comorbidities
Timeframe: Baseline
Renal histopathological parameters: Number of participants with presence of cysts
Timeframe: Baseline
Renal histopathological parameters: Number of participants with presence of tumors
Timeframe: Baseline
Renal histopathological parameters: Number of participants with presence of interstitial fibrosis or tubular atrophy
Timeframe: Baseline
Renal histopathological parameters: Number of participants with presence of glomerulosclerosis
Timeframe: Baseline
Renal histopathological parameters: Endocapillary hypercellularity
Timeframe: Baseline
Renal histopathological parameters: Neutrophils in capillary lumens (each glomerulus is scored)
Timeframe: Baseline
Renal histopathological parameters: Mesangial hypercellularity
Timeframe: Baseline
Renal histopathological parameters: Necrosis
Timeframe: Baseline
Renal histopathological parameters: Cellular or fibrocellular crescents
Timeframe: Baseline
Renal histopathological parameters: Activity index
Timeframe: Baseline
Renal histopathological parameters: score inflammation assessment scale
Timeframe: Baseline
Renal histopathological parameters: Number of participants by typo of inflammation
Timeframe: Baseline
Chronicity index parameters: Number of participants with glomerular (or segmental) sclerosis
Timeframe: Baseline
Chronicity index parameters: Number of participants with Fibrous crescents
Timeframe: Baseline
Chronicity index parameters: Number of participants with tubular atrophy
Timeframe: Baseline
Chronicity index parameters: Number of participants with interstitial fibrosis
Timeframe: Baseline
Renal histopathological parameters: Chronicity index
Timeframe: Baseline