Journal Article

Randomized trial of FX high flux <i>vs</i> standard high flux dialysis for homocysteine clearance

David W. Mudge, Robyn Rogers, Peter Hollett, Belinda Law, Kylie Reiger, James J. B. Petrie, Lee Price, David W. Johnson, Scott B. Campbell, Nicole M. Isbel, Matthew Sullivan and Carmel M. Hawley

in Nephrology Dialysis Transplantation

Published on behalf of European Renal Association - European Dialysis and Transplant Assoc

Volume 20, issue 10, pages 2178-2185
Published in print October 2005 | ISSN: 0931-0509
Published online July 2005 | e-ISSN: 1460-2385 | DOI: http://dx.doi.org/10.1093/ndt/gfh987
Randomized trial of FX high flux vs standard high flux dialysis for homocysteine clearance

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Background. Cardiovascular disease is the major cause of death in the end-stage renal disease population. Novel risk factors such as homocysteine (Hcy) are of considerable interest in this group as hyperhomocysteinaemia is highly prevalent in the setting of renal impairment. Folic acid–vitamin B group therapies are only partially effective treatments. Hcy is highly protein-bound and thus poorly dialysed. Dialyzers with albumin-leaking properties have been shown to result in lowering of plasma Hcy. As the FX-class (Advanced Fresenius Polysulfone dialyzer) has greater clearance of larger molecular weight substances but is non-albumin-leaking, we explored the capacity of this new technology membrane to reduce plasma Hcy levels.

Methods. A prospective randomized cross-over trial in 35 prevalent haemodialysis patients, one group receiving 12 weeks dialysis using FX dialyzer then 12 weeks with standard high flux dialysis (SHF) and the other group SHF followed by FX dialyzer. All patients received vitamin B6 25 mg and folic acid 5 mg daily throughout the study.

Results. The primary outcome was plasma Hcy pre-dialysis at week 12. FX vs SHF showed no significant difference, 25±6.6 vs 25.9±5.8 µg/l, Δ95% CI = −2.77 to 4.59, P = 0.31. There was a non-significant trend toward a decrease in Hcy in both groups (27.43±7.68 to 25.91±5.78 µmol/l for SHF, P = 0.23 and 26.0±4.58 to 25.0±6.61 µmol/l for FX, P = 0.28). Analysis by repeated measures method demonstrated a statistically significantly lower Hcy with FX vs SHF dialyzer (adjusted β = −1.30, 95% CI = −2.41 to −0.19, P = 0.022). Kt/Vurea was higher in FX vs SHF (1.35±0.18 vs 1.22±0.2; P = 0.013). Folate and B6 levels did not change.

Conclusions. The primary outcome analysis did not show any significant difference in pre-Hcy comparing FX and SHF membranes. Although our secondary analysis demonstrated a statistically significant difference between membranes, the magnitude of the difference (1.3 μmol/l) is not clinically significant. Thus the use of the FX dialyzer did not result in a clinically significant benefit in relation to improving pre-dialysis Hcy compared with standard high-flux dialysis.

Keywords: dialyzer membrane; dialysis; FX-class dialyzer; haemodialysis; high-flux; plasma homocysteine

Journal Article.  4310 words.  Illustrated.

Subjects: Nephrology

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