2024-513644-28-00招募中2 期
Efficacy and safety of Ursodeoxycholic Acid as a new therapy for the treatment of hepatorenal polycystic diseases, genetic study and determination of prognostic biomarkers.
Asociacion Instituto Biogipuzkoa1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年11月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The primary endpoint is the absolute and percentage change in total liver cyst volume (TLCV) at the beginning and the end of treatment between the two groups.
研究概览
简要总结
To evaluate the therapeutic efficacy of UDCA versus placebo in patients with PLD by decreasing the total liver cyst volume (TLCV) growth (prevention of disease progression).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 80 years (inclusive).
- •Diagnosed liver or hepatorenal polycystic disease and total liver volume 2000-5000 mL.
- •PLD defined as >10 liver cysts and PKD defined as: - At least 2 kidney cysts or 1 cyst in each kidney in patients younger than 30 years. - At least 2 cysts in each kidney in patients aged 30-59 years old. - At least 4 cysts in each kidney in patients aged 60 years or older.
- •Not be candidates for intervention (aspiration or surgical intervention) at the time of inclusion.
排除标准
- •TLV >5000 mL
- •Chronic liver disease unrelated to PLD.
- •Intervention (aspiration or surgical intervention) in the previous 6 months.
- •Treatment with somatostatin analogues in the previous 6 months.
- •Hypersensitivity to UDCA or patients with galactose intolerance or malabsorption, or lactase deficiency.
- •Acute cholecystitis or frequent attacks of biliary colic.
- •Treatment with tolvaptan in the previous 6 months.
- •Renal dysfunction (MDRD- GFR ≤ 30 ml/min/1.73m2).
- •Use of hormonal contraceptives or estrogen supplements in the previous 6 months.
- •Inclusion in another clinical trial while participating in this study.
- •Pregnant or lactating women, or subjects of childbearing potential who are not using an effective method of contraception.
- •History or other evidence of serious illness or any other condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
- •Gastric or duodenal ulcers.
- •Use of drugs that may interact with UDCA, such as cholestyramine or aluminum hydroxide.
- •Treatment with UDCA in the previous 6 months
研究组 & 干预措施
URSODEOXYCHOLIC ACID
Test
干预措施: URSODEOXYCHOLIC ACID (Drug)
结局指标
主要结局
The primary endpoint is the absolute and percentage change in total liver cyst volume (TLCV) at the beginning and the end of treatment between the two groups.
The primary endpoint is the absolute and percentage change in total liver cyst volume (TLCV) at the beginning and the end of treatment between the two groups.
次要结局
- Safety: occurrence of serious adverse events related to the medication and any events occurring during the patient's participation in the trial.
- Genetic profile: centralized analysis of genes described for the disease.
- (Exploratory endpoint) - Demographic variables (age, sex).
- (Exploratory endpoint) - Medical history.
- (Exploratory endpoint) -Concomitant medication and adherence to treatment.
- (Exploratory endopoint) - Physical examination (body weight, height, blood pressure, heart rate).
- Quality of life: SF-36 questionnaire.
- Liver volume: absolute and proportional change in liver volume (TLV/hTLV).
- Renal volume: absolute and proportional change in renal volume (TKV/hTKV).
- Renal function: glomerular filtration rate (GFR), serum creatinine, indication for dialysis or renal transplantation.
- Laboratory values: haematology, biochemistry, hormones, coagulation, liver profile (ALT, AST, γGT, ALP, Bi) and CA-19-9.
- Symptomatology: to be assessed at each visit to the centre using the PLD-Q questionnaire.
- (Exploratory endopoint) - Kidney cyst volume: absolute and proportional change in renal cyst volume change (TKCV), at the baseline visit, at one year and at the end of treatment.
- (Exploratory endopoint) - Association analysis between genotype and clinical response to treatment.
- (Exploratory endopoint) -Treatment response markers based on proteins, RNA, and/or circulating metabolites, among others (liquid biopsy).
- (Exploratory endopoint) - Correlation of biomarker levels with: - TLV / hTLV, TLCV and TKV / hTKV and its progression over time, - Clinical response - Liver and kidney function parameters.
研究者
Unidad de Investigación Clínica
Scientific
Asociacion Instituto Biogipuzkoa
研究点 (1)
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