A single arm, non-randomised device trial to assess the effect of the Theranova Dialyser on albumin and uraemic solutes in patients with Stage V chronic kidney disease requiring haemodialysis

The University of Queensland0 个研究点目标入组 91 人开始时间: 2016年6月21日最近更新: 2021年7月5日

适应症

试验速览

暂无简介。

•1.Established chronic in-centre HD patient (>12 weeks on HD)
•2.Has a functioning Arterio Venous Fistula or Graft
•3.Either oliguric (<500mls/24hrs based on 24hr urine collection within 12 weeks of screening) or anuric
•4.Able to give informed consent

•1.Planned renal transplant within study intervention period
•2.Planned conversion to peritoneal dialysis or transfer to another dialysis unit within study intervention period
•3.Active chronic infection or significant active inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
•4.Life expectancy <12 months
•5.Pregnancy or breast feeding
•6.Indication for HDF according to treating physician
•7.Dialysis catheter in situ
•8.Receiving immunosuppressant medication
•9.Current use of nutritional or dietary supplements to increase or reduce protein intake including protein powder or weight loss supplements and is unable to cease the supplement
•10.Serum albumin <30g/L (within 4 weeks of screening)
•11.Inability to complete study assessments

发起方