Impact of medium cut-off membrane on FGF-23 level in HD patients
Research type
Research Study
Full title
Impact of medium cut-off membrane on FGF-23 level in Haemo-dialysis patients
IRAS ID
262813
Contact name
Dimitrios Poulikakos
Contact email
Sponsor organisation
Salford Royal NHS Foundation Trust
Duration of Study in the UK
0 years, 2 months, 15 days
Research summary
End stage renal disease leads to accumulation of different sized molecules and toxins. Dialysis patients routinely undergo haemodialysis (HD) treatment three times per week. Standard dialysis treatment utilizes traditional dialysis membranes which provide size specific clearance lead to accumulation of larger molecules {such as Fibroblast Growth Factor-23 (FGF-23) molecular weight: 32 KiloDaltons (KDa)}. Accumulation of FGF-23 is thought to be associated with increased cardiovascular events and overall mortality in dialysis patients. Newer dialysis membranes so called medium cut-off (MCO) membrane (e.g Theranova by Baxter Healthcare) can potentially clear relatively bigger sized molecules due to bigger pore size No data is available regarding clearance of FGF-23 on MCO membranes. The aim of this study is to investigate the new membranes can remove FGF 23.
This study will include adult patients with renal failure who are on long term HD at Bolton and Salford HD Units which are parts of is a satellite unit of Salford Royal NHS Foundation Trust. During this study, patients will be randomized to 1 week monitored HD treatment with MCO membrane followed by 1 week monitored conventional HD or to receive 1 week monitored conventional HD followed by 1 week monitored MCO membrane treatment. Both options will include a 3-week interval between monitored sessions during which the patients will receive conventional HD. Blood samples will be collected before and after dialysis during monitored treatment week. Blood samples will be tested for FGF-23 levels but also for calcium, phosphate levels, Vitamin D and PTH levels which are known to affect FGF-23 levels. In addition to blood sample, dialysate generated during the monitored dialysis session will be collected and analyzed for solute levels including FGF-23 levels.
Generated data will be analysed to compare clearance of FGF-23 on conventional dialysis membranes versus clearance on MCO membrane and rate of re-accumulation of FGF-23 between dialysis sessions. If the new membrane is effective in removing FGF 23 further studies should explore the impact of the new membranes on cardiovascular profiles and cardiovascular outcomesREC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0638
Date of REC Opinion
19 Nov 2019
REC opinion
Favourable Opinion