The Long-term Effect of Marine n-3 Polyunsaturated Fatty Acid Supplementation on Glomerular Filtration Rate and Development of Fibrosis in the Renal Allograft: a Randomized Double Blind Placebo Controlled Intervention Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 6
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
This is a long-term intervention study on the effects of marine n-3 PUFAs in renal transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation will have less decline in kidney transplant function compared to patients treated with placebo.
详细描述
The study is designed as a randomized, double blind, placebo controlled, multi-center trial of 174 renal transplant recipients. Patients will be randomized to oral supplementation of marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.
The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the treatment group compared with the control group. Secondary endpoints include the following variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate, fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft rejections and graft losses, and number of cardiovascular events and deaths.
Patients from Akershus University Hospital will also participate in a sub-study, where renal graft biopsies will be performed to assess the degree of fibrosis and chronic allograft damage index (CADI) and markers of fibrosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Renal transplant recipients over 18 years of age.
- •Stable renal graft function, defined as eGFR >30 ml/min at the last 2 visits.
- •6-60 months post-transplantation at randomization.
- •Signed informed consent.
排除标准
- •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug.
- •Women who are pregnant or breastfeeding.
- •Patients who participate in a clinical trial with other investigational drugs.
- •Patients with a history of an allergic reaction or significant sensitivity to fish, seafood and the study drug Omacor or drugs or dietary supplements similar to the study drug.
- •Any reason why, in the opinion of the Principal Investigator, the patient should not participate - E.g. history of repeated non-adherence to prescribed treatment, repeated non-attendance to clinic visits, cognitive impairment that prevents understanding the nature of this study, etc.
研究组 & 干预措施
Marine n-3 PUFAs
3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA).
干预措施: Omacor (Drug)
Placebo
Corresponding placebo oral capsules with olive oil, three capsules daily.
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Glomerular filtration rate
时间窗: 156 weeks
Estimated by CKD-EPI equation
次要结局
- Body mass index(156 weeks)
- Plasma fatty acid levels(156 weeks)
- Proteinuria(156 weeks)
- Blood pressure(156 weeks)
- Resting heart rate(156 weeks)
- Lipid and lipoprotein concentrations(156 weeks)
- Heart rate variability(156 weeks)
- Fatty acid levels in renal cortical tissue(156 weeks)
- Plasma inflammatory biomarkers(156 weeks)
- Fasting serum glucose / HbA1c(156 weeks)
- The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue(156 weeks)
- Markers of fibrosis in renal cortical tissue(156 weeks)
研究者
Joe Chan
MD, PhD
University Hospital, Akershus