A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
2期
提前终止
NCT05524051
| 适应症 | Acute Kidney Injury Following Cardiac Surgery |
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| 分期 | 2期 |
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| 申办方 | Novartis Pharmaceuticals |
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| 状态 | 提前终止 |
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| 受试者人数 | 102 人 |
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| 干预（药物） | TIN816 |
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| 开始日期 | 2023年3月3日 |
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| 完成日期 | 2025年3月26日 |
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| 结果公布日 | 2026年4月2日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。