Effect of Long-acting Somatostatin on Liver in Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Effect of somatostatin on liver volume
研究概览
简要总结
Autosomal dominant polycystic kidney disease (ADPKD) is associated with the development of a variety of extrarenal manifestations of which polycystic liver disease is most common. The investigators aimed to assess the changes over time of liver volume in ADPKD patients and whether it is affected by the treatment with the somatostatin analogue, octreotide.
35 ADPKD patients (14 males) aged 34±8 years were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and liver parameters at magnetic resonance (RM) were evaluated at baseline, study end and after 24 months of drug withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of autosomal dominant polycystic kidney and liver disease
- •glomerular filtration rate greater than 40 ml/min
排除标准
- •diabetes mellitus
- •proteinuria greater than 1 g/24 hours
- •significant glomerular disease
- •urinary tract lithiasis and infections
- •symptomatic gallstones
- •biliary sludge
- •pregnant women
- •lactanting women
研究组 & 干预措施
OCTEOTRIDE
octeotride 20 mg, intramuscular injection monthly for 3 years
干预措施: octeotride (Drug)
Placebo
Placebo (saline soluction), intramuscular injection monthly for 3 years
干预措施: placebo (Drug)
结局指标
主要结局
Effect of somatostatin on liver volume
时间窗: 3 years
次要结局
未报告次要终点
研究者
Eleonora Riccio
MD
Federico II University