Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Baseline demographic | Age and sex | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Time of IgAN diagnosis | Time of IgAN diagnosis and biopsy that's related with the IgAN dianosis | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Baseline MEST-C | Scored according to the Oxford classification MEST-C criteria:
| Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Index Blood Pressure | Index date (date of iptacopan or atrasentan initiation) | |
| Baseline clinical characteristics: Index eGFR | Index date (date of iptacopan or atrasentan initiation) | |
| Baseline clinical characteristics: Index proteinuria | Index date (date of iptacopan or atrasentan initiation) | |
| Baseline clinical characteristics: Index hematuria | Index date (date of iptacopan or atrasentan initiation) | |
| Baseline clinical characteristics: Index serum albumin level | Index date (date of iptacopan or atrasentan initiation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 24-months |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Patients with IgAN (≥18 years) to be treated with iptacopan or atrasentan in the real-world setting
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline clinical characteristics: Index creatinine level | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Number of participants by Index CKD stage | CKD stages:
| Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Number of participants by ESKD status | ESKD status is a binary variable, meaning with or without ESKD | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: History of dialysis and kidney transplant | Number of participants with history of dialysis and kidney transplant | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Baseline use of corticosteroids or targeted Budesonide for IgAN | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Baseline use of ACEi, ARB and SGLT2i treatments | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Baseline use of ERA, APRIL / APRIL-BAFF therapies, MMF, Hydroxychloroquine, nsMRA , Immunosuppressant | Baseline use of Endothelin Receptor Antagonist (ERA), A Proliferation Inducing Ligand (APRIL) / A Proliferation Inducing Ligand-B-cell Activating Factor (APRIL-BAFF) therapies, MMF, Hydroxychloroquine, nsMRA (Finerenone), Immunosuppressant | Index date (date of iptacopan or atrasentan initiation) |
| Baseline clinical characteristics: Number of participants who have participated in a clinical trial | Index date (date of iptacopan or atrasentan initiation) |
| Proteinuria |
| Up to 24-months |
| Proteinuria control rate | Proteinuria control rate (below 0.5g/day or 0.3g/day) | Up to 24-months |
| eGFR | Up to 24-months |
| Time from index date to complete remission | complete remission defined as 24h proteinuria <0.3 g/d at various time intervals, depending on data availability (i.e. 6, 12, 18 and 24 months, etc.) until the date of treatment discontinuation (iptacopan or atrasentan), death, or loss to follow-up, whichever occurs first. | Up to 24-months |
| Change in Chronic Kidney Disease (CKD) stage | Up to 24-months |
| Number of patients progressing to kidney failure | Up to 24-months |
| Number of patients receiving dialysis | Up to 24-months |
| Number of patients progressing to of kidney transplantation | Up to 24-months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |