A tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients
Principal Investigators: Dr Colin Hutchison
Clinical Project Manager: Laura Robison (AKTN)
Clinical Research Associate: Peta-Anne Paul-Brent (AKTN)
Trial Number: AKTN 15.01
Population: Adults on haemodialysis with functioning AVF/G and low urine output
Intervention: nK3 PUFA (fish oil) 4g/day or matched placebo
Primary outcome: Change in pre-dialysis concentrations of central serum albumin between baseline and 6 months.
Final Recruitment: 92/85 participants
Status: Data Analysis underway
Haemodialysis remains a principal renal replacement modality for patients with end stage kidney disease (ESKD). Despite the efficacy of haemodialysis as a treatment to replace essential kidney functions, such as fluid and acid-base balance, the morbidity and mortality of patients receiving haemodialysis remains high when compared with the general population. Of many factors, the inadequate removal of some uraemic solutes might play a role in this phenomenon. Middle molecules are a well described class of uraemic solutes which have been linked to both the reduced quality of life and survival associated with ESKD. To date larger middle molecules have been inadequately removed by haemodialysis strategies. The mid cut-off dialyser Theranova represents a new class of dialysis membranes with the ability to remove nearly all middle molecules.
REMOVAL-HD is a pivotal, open label, non-randomised, single-arm, multi-centre device study. The primary objective of the study is to determine if regular haemodialysis using the Baxter Theranova mid cut-off (MCO) dialyser in a chronic haemodialysis population is safe and will not result in a significant loss of albumin. The study will also assess the efficacy of large middle molecules removal using this MCO dialyser. Participants had 4 weeks wash-in period of high flux haemodialysis, then 24 weeks of treatment with Theranova MCO dialyser and then 4 weeks wash-out with high flux haemodialysis.
Click here to view the Statistical Analysis Plan.