NL-OMON36219已完成4 期
A Multi-center, Longitudinal, Observational Study of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression - Otsuka No. 156-10-291
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Ages 12 to 70 years, inclusive (18 to 70 inclusive in the Netherlands)
- •2. Existing diagnosis of ADPKD by modified-Ravine criteria:
- •With family history: several cysts per kidney (3 if by sonography, 5 if by computerized
- •tomography or MRI)
- •Without family history: 10 cysts (by any radiologic method) per kidney and exclusion of other
- •cystic kidney diseases
- •3. Ability to provide written, informed consent/assent prior to initiation of any study-related
- •procedures, and ability, in the opinion of the investigator, to comply with all requirements of the
- •4. Total kidney volume >= 300 cc/m height by ultrasound (within 1 year prior to baseline) or >= 250
- •cc/m height by MRI (within 1 year prior to baseline).
排除标准
- •1. Any medical condition, in the opinion of the Investigator, that could interfere with evaluation of the study objectives (eg, inability to comply with MRI)
- •2. Current or expected (within the next six months) interventions for the treatment of ADPKD
- •affecting kidney volume without the prior approval of the sponsor
研究者
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