MoDal Study
Research type
Research Study
Full title
A Randomised Pilot Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line Haemodiafiltration
IRAS ID
239423
Contact name
Sandip Mitra
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
More than 25,000 patients in the UK are currently receiving haemodialysis treatment for end stage kidney disease. Whilst it is a necessary treatment option for many, survival for dialysis patients remains poor. Quality of life on dialysis is considerably poorer than those treated with a kidney transplant and patients experience a high burden of symptoms.
Until recently, there has been a focus on improving outcomes through increasing the dose of dialysis (based on the clearance of small sized toxins). Attention is now focusing on other avenues including the clearance of larger sized toxins which are known as “middle molecules” as further dialysis dose increases do not improve survival.
Whilst hemodialysis is efficient at clearing smaller sized toxins, middle molecules are not efficiently cleared and some are too large to pass through the pores of the artificial kidney used in current haemodialysis machines. A different way of providing dialysis (haemodiafiltration) allows improved clearance of some middle molecules and there is a signal that the use of this treatment is associated with improved patient outcomes. The provision of this treatment is not possible by all hospitals and the treatment can be more costly to provide.
Recently, a membrane has been developed for haemodialysis which allows improved clearance of middle molecules compared with both haemodialysis and haemodiafiltration. This device (Theranova) has been fully tested for safety however the true benefit to patients is yet to be explored.
This study will explore the effects of haemodialysis treatment with Theranova and compare it with haemodiafiltration. The study will focus on benefits to the health of blood vessels as the majority of deaths in dialysis patients are related to the cardiovascular system. There will also be a focus on patient symptoms, dialysis recovery time and several other parameters.
REC name
North West - Preston Research Ethics Committee
REC reference
18/NW/0169
Date of REC Opinion
9 May 2018
REC opinion
Further Information Favourable Opinion