Lanreotide In Polycystic Kidney Disease Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate (GFR)
研究概览
简要总结
LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.
An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.
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
- •autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds)
- •measured GFR : 30 to 89 ml/mn/1.73m2
- •age > 18
- •affiliated with health insurance
- •written informed consent
排除标准
- •iohexol /iodine allergy
- •diabetes mellitus
- •other associated nephropathy suspected
- •evolutive or recent malignant disease ( in the previous 5 years)
- •cholelithiasis
- •uncontrolled hypertension (BP>160/100 mmHg)
- •cardiac failure of grade III or IV according to the NYHA (New York Heart Association) classification
- •liver failure
- •psychiatric illness
- •pregnancy, lactation, lack of contraception
- •use of somatostatin analogs during the last 6 months
研究组 & 干预措施
A - treated group
干预措施: Lanreotide (Drug)
B - control group
干预措施: saline (Drug)
结局指标
主要结局
Glomerular filtration rate (GFR)
时间窗: month 36
次要结局
- Glomerular filtration rate (GFR)(month 18)
- Quality of life(month 36)
- Glomerular filtration rate (GFR) decline(month 36)
- Safety, tolerance(month 36)
- Onset or worsening of hypertension(month 36)
- Cystic pain(month 36)