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The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iptacopan | patients administered iptacopan in clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with infections | Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period | 360 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and adverse reactions | Incidence of adverse events and adverse reactions that occurred during the treatment period | 360 Days |
| Changes in UPCR | Changes in UPCR from baseline to Day 360 and from baseline to 360 days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who received Fabhalta.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8650 | Japan | ||
| Novartis Investigative Site |
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| Baseline, 360 Days |
| Changes in eGFR | Changes in eGFR from baseline to Day 360 and from baseline to 360 days | Baseline, 360 Days |
| Proportion of patients achieving the composite renal endpoint at the final assessment. | The composite renal endpoint requirement will be met if the following criteria are met: (1) stable or improved eGFR relative to start of treatment (≤ 15% reduction in eGFR) and (2) decrease in UPCR by ≥ 50% relative to start of treatment. Initiation of a complement pathway modulator, initiation/intensification of corticosteroids or immunosuppressants (e.g., MMF) for C3 glomerulopathy, or renal replacement therapy will be determined as failure of the endpoint. | 360 Days |
| Changes in blood urea nitrogen (BUN) | Changes in blood urea nitrogen over the course of treatment | 360 Days |
| Changes in serum albumin | Changes in serum albumin over the course of treatment | 360 Days |
| Changes in serum creatinine | Changes in serum creatinine over the course of treatment | 360 Days |
| Toyoake |
| Aichi-ken |
| 4701192 |
| Japan |
| Novartis Investigative Site | Hirosaki | Aomori | 0368563 | Japan |
| Novartis Investigative Site | Chiba | Chiba | 2608677 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 810-8563 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 8028555 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 0040041 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 0608604 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | 3058576 | Japan |
| Novartis Investigative Site | Komatsu | Ishikawa-ken | 923-0961 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-8682 | Japan |
| Novartis Investigative Site | Tosa-gun | Kyoto | 629-2261 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-8507 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8501 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 5698686 | Japan |
| Novartis Investigative Site | Kusatsu | Shiga | 525-8585 | Japan |
| Novartis Investigative Site | Ohtsu | Shiga | 5202192 | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | 420-8527 | Japan |
| Novartis Investigative Site | Shimotsuga Gun | Tochigi | 3210293 | Japan |
| Novartis Investigative Site | Tokushima | Tokushima | 7708503 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Novartis Investigative Site | Fuchū | Tokyo | 1838561 | Japan |
| Novartis Investigative Site | Nakano City | Tokyo | 164-8607 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 1628666 | Japan |
| Novartis Investigative Site | Hiroshima | 7348530 | Japan |
| Novartis Investigative Site | Ishikawa | 9208641 | Japan |
| Novartis Investigative Site | Nara | 630-8581 | Japan |
| Novartis Investigative Site | Wakayama | 640-8558 | Japan |