EUCTR2022-002681-32-DE招募中1 期
umasiran in hyperoxalaemic patients on haemodialysis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Both male and female patients
- •Aged between =18 and =80 years old
- •Women of child-bearing age to consent to either abstinence or the use of contraception during the study period
- •Patients must have capacity to give written, informed consent to participate in the study prior to commencing the study. They must be fully aware of the aims, nature, planned interventions and potential risks of participating in the study
- •Established and stable on haemodialysis for at least 2 months
- •Thrice weekly haemodialysis
- •In possession of permanent dialysis access – either arterio-venous fistula (AVF) or graft (AVG) or permanent dialysis catheter/tunnelled haemodialysis line (THL)
- •Any cause of ESKD except previously diagnosed primary hyperoxaluria.
- •Baseline serum oxalate level of >20 µmol/L
- •No recent (within last 2 months) significant changes to regular medications or diet
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Age less than 18 or over 80 years old
- •Known diagnosis of PH1, 2 or 3; or a pathological mutation documented to cause primary hyperoxaluria
- •Established on haemodialysis for less than 3 months or on peritoneal dialysis or combined haemodialysis and peritoneal dialysis
- •Temporary or poorly functioning haemodialysis access
- •Pregnancy, planning pregnancy or currently breast feeding
- •Co-morbidity of an enteric disorder such as Inflammatory Bowel Disease (IBD), short gut syndrome, or a malabsorptive disorder.
- •Decompensated Liver failure
- •Intercurrent active infection and/or antibiotic treatment
- •Currently on Vitamin C treatment with a daily dose of more than 250mg
- •Terminal illness and/or life expectancy of less than 1 year
- •Currently relapsed or uncontrolled and symptomatic psychiatric disorder preventing compliance with the study
- •Patients who could be coerced due to dependency on the sponsor, the investigator or the trial sites
- •Deranged LFTs: If alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than twice the upper limit of normal, or if the total bilirubin is above 1.5x the upper limit of normal. If the patient is diagnosed with Gilbert’s syndrome then a total bilirubin up to twice the upper limit of normal is acceptable
- •Deranged clotting: Patients with an International normalised ratio (INR) of more than 2.0 will be excluded unless they are oral therapeutic anticoagulants in which case only an INR >3.5 will be unacceptable.
- •A history of multiple medical drug allergies or a history of allergy to an oligonucleotide or GalNAc
- •Currently taking any other investigational agent
研究者
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