The Effect of Lanreotide on Volume of Polycystic Liver and Kidney in Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Liver volume
研究概览
简要总结
The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.
详细描述
The aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR, blood pressure, and urinary tubular damage markers and serum biomarker FGF23.
The investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. Eligible patients will be invited to participate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ADPKD with polycystic liver (> 20 liver cysts)
- •Renal function MDRD >40 ml/hr
- •Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements
排除标准
- •Kidney transplantation
- •Renal failure requiring hemodialysis
- •Use of oral contraceptives or estrogen suppletion
- •Women who are pregnant or breastfeeding
- •History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc
- •Intervention (aspiration or surgical intervention) within three months from baseline
- •Treatment with somatostatin analogues within three months from baseline
- •Mental illness that interferes with the patient ability to comply with the protocol
- •Drug or alcohol abuse within one year from baseline
- •Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD)
- •Clinical diagnosis of pancreatitis
- •Diagnosis of diabetes mellitus, as determined by blood test and medical history
- •Use of drugs that can interact with lanreotide, such as cyclosporin
研究组 & 干预措施
Lanreotide
干预措施: Lanreotide (Drug)
结局指标
主要结局
Liver volume
时间窗: 24 weeks
Change in total liver volume between baseline and 24 weeks, as determined by CT volumetry
次要结局
- Kidney volume(24 weeks)
- quality of life(24 weeks)
- Blood pressure(24 weeks)
- Symptoms(24 weeks)
- Urinary tubular damage markers(24 weeks)
- Adverse events(24 weeks)
- Glomerular filtration rate(24 weeks)