JPRN-UMIN000015245已完成未知
Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. - ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.
Department of Nephrology, Tokyo Women's Medical University0 个研究点目标入组 92 人开始时间: 2014年9月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 92
研究概览
简要总结
The observation period was 2.4 years. U-AQP2 per milligram of urinary creatinine (U-AQP2/Cr) decreased from 67.8 to 20.7 fmol/mg urinary creatinine after 1 month of tolvaptan treatment. This initial change in U-AQP2/Cr was correlated with high baseline U-AQP2/Cr, low baseline eGFR, and a large initial change in eGFR (baseline to 1 month). The initial change in U-AQP2/Cr (baseline to 1 month) was strongly correlated with the annual change in TKV and eGFR in multivariable analysis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) contraindicated patient of tolvaptan 1. patient who has past history of hypersensitivity to tolvaptan or similar compound (mozavaptan) 2. patient who is not able to feel thirst or is difficult to water intake. 3. hypernatremia 4. severe kidney dysfunction (eGFR less than 15mL/min/1.73m2) 5. present or past history of liver dysfunction by chronic hepatitis, or drug-induced liver dysfunction, excluding liver cyst in ADPKD 6. The pregnancy or the woman who may be pregnant. (2) The patient judged inappropriate by study responsibility doctor.
研究者
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