NL-OMON34527已完成2 期
A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function - Phase 2a study in adult subjects with ADPKD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Covance
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •This study will be started in subjects with eGFR >30 mL/min*1.73m2. Other important inclusion criteria are: confirmed diagnosis of ADPKD, body mass index of <35 kg/m2, in good health determined by: medical history, physical examination, ECG, serum/urine biochemistry, hematology tests. See protocol page 29.
- •Following determination of the effects in patients with eGFR >30 mL/min*1.73m2, subjects with eGFR <30 mL/min*1.73m2 will be entered as appropriate. If necessary, subjects withdrawn from the trial will be replaced.
排除标准
- •- Subjects with previous exposure to tolvaptan
- •- Subjects with recent (within last 6 months) renal surgery
- •- Subjects with evidence of renal cystic disease other than ADPKD (e.g. renal cancer)
- •- Safety contraindications including: reproductive precautions, unawareness of thirst, severe allergic reactions to compounds with similar chemical structure as tolvaptan, significant risk factors for renal impairment other than ADPKD (e.g. advanced diabetes), a history of significant coagulation defects, critical electrolyte inbalances, low blood volume, clinically significant anemia, history of substance abuse, uncontrolled hypertension.
- •- Contraindications to or interference with MRI assessments
- •See protocol page 30 for further details.
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