The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the real-world clinical care setting immediately from the time of drug launch. Furthermore, this study is planned to contribute to a global meta-analysis, to enable further analysis with greater statistical power, as well as exploration of similarities and differences of treatment use and outcomes between countries and regions. Each patient will be observed for 24 months
Biopsy confirmed diagnosis of IgAN.
Age ≥18 years at index date.
Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician.
Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform.
Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan/atrasentan.
Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records.
Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician.
Patients with IgAN (≥18 years) to be treated with iptacopan or atrasentan in the real-world setting
Cohort
Prospective
Not listed
Baseline demographic
Age and sex
Baseline clinical characteristics: Time of IgAN diagnosis
Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis
Baseline clinical characteristics: Baseline MEST-C
Scored according to the Oxford classification MEST-C criteria: * Mesangial hypercellularity (M0/M1) * Endocapillary hypercellularity (E0/E1) * Segmental glomerulo- sclerosis (S0/S1) * Tubular atrophy/interstitial fibrosis (T0/T1/T2) * Crescents (C0/C1/C2)
Baseline clinical characteristics: Index Blood Pressure
Number of participants by treatment sequence during baseline and follow-up period
Treatment sequence refers to longitudinal sequence of lines of treatment received across the study period. The date of treatment initiation and discontinuation will be recorded to determine the number of participants by sequence of treatment.
Proteinuria
Proteinuria control rate
Proteinuria control rate (below 0.5g/day or 0.3g/day)
eGFR
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This trial is not recruiting at the moment. You can still explore other options:
