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Clinical Trial Summary

The study will compare achieved levels of protein-bound uremic toxins with dialysis using a medium cut-off membrane compared to the treatment by online haemodiafiltration with a high-flux dialysis membrane. In the second phase of the study dietary fiber and short-chain fatty acid intake will be increased to verify a possible additional reduction in the levels of protein bound uremic toxins.


Clinical Trial Description

The investigators will carry out a prospective interventional randomised study to compare achieved serum concentrations of selected protein bound uremic toxins by dialysis with a medium cut-off membrane (Theranova, Baxter AG, USA) and online hemodiafiltration with a standard "high-flux" dialysis membrane. In the second phase, both dialysis purification methods will be supplemented by a change in the diet with increase of the daily intake of dietary fiber to 30g and addition of a short-chain fatty acid propionate in the dose of 1 g daily. The main outcome of the study is the serum concentration of p-cresol sulphate. Secondary outcome is the serum concentration of indoxyl-sulphate and trimethylamine-N-oxide (TMAO). Serum albumin concentration and lean body weight of patients represent safety outcomes for this study. This investigator-initiated research project has been entirely planned and will be conducted by the clinical researchers in a tertiary University Medical Center Ljubljana. The study will include 50 chronic prevalent stable dialysis patients in the following periods: - 2 weeks of wash-in period with standard bicarbonate haemodialysis and standard high-flux dialysis membrane, - then the patients will be randomized in a 1:1 ratio to either one of the two study arms: - (interventional study arm) 4 weeks of dialysis with medium cut-off (Theranova) membrane (first phase), then dialysis for 4 weeks with the same membrane and increased fiber intake (second phase), - (control study arm) 4 weeks of dialysis with a high-flux membrane using on-line haemodiafiltration (first phase) and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake (second phase), - finally, all patients will undergo a 4 week wash-out period with a standard bicarbonate haemodialysis using standard high-flux dialysis membrane identical to wash-in period. Measurement of the study end-points will be carried out at the end of 2-week wash-in period, each 4-week period and at the end of 4 week wash-out period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04247867
Study type Interventional
Source University Medical Centre Ljubljana
Contact Jernej Pajek, MD, PhD
Phone +38615228124
Email jernej.pajek@mf.uni-lj.si
Status Recruiting
Phase N/A
Start date August 31, 2020
Completion date October 31, 2022

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