A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
Фаза 2
Прекращено
NCT05524051
| Заболевание | Acute Kidney Injury Following Cardiac Surgery |
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| Фаза | Фаза 2 |
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| Спонсор | Novartis Pharmaceuticals |
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| Статус | Прекращено |
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| Участники | 102 участн. |
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| Вмешательство | TIN816 |
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| Дата начала | 3.03.2023 |
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| Дата завершения | 26.03.2025 |
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| Публикация результатов | 2.04.2026 |
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Кратко
This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.
Ratio of the Highest Serum Creatinine Value up to and Including Study Day 6 Versus Baseline
Baseline, Day 1 - Day 6 · ratio
| TIN816 2 mg/kg | 1.215 ratio |
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| TIN816 4 mg/kg | 1.318 ratio |
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| Placebo | 1.226 ratio |
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| p-value | 0.4543 |
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| geometric mean ratio | 0.991 (95% CI 0.87–1.13) |
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