A randomized controlled trial evaluating the erythropoiesis stimulating agent sparing potential of a vitamin E-bonded polysulfone dialysis membrane

Nephrol Dial Transplant. 2014 Mar;29(3):649-56. doi: 10.1093/ndt/gft481. Epub 2013 Nov 28.

Abstract

Background: Vitamin E (VE) bonded polysulfone dialysis membranes have putative erythropoiesis stimulating agent (ESA)-sparing and anti-inflammatory properties based on data from a small number of studies. We sought to investigate this in a large, prospective 12-month randomized controlled trial.

Methods: Two-hundred and sixty prevalent haemodialysis (HD) patients were randomized to dialysis with VE-bonded polysulfone membranes or non-VE-bonded equivalents. All ESA-dosing was performed by means of a computer-based anaemia management decision support system. Monthly data were used to calculate the ESA resistance index (ERI) and blood tests were performed at baseline, 6 and 12 months for measurement of C-reactive protein (CRP) levels.

Results: Of the 260 patients, 123 were randomized to dialysis with the VE-membrane and 12-month data was available for 220 patients. At the study population level, no beneficial effect of the VE membranes on the ERI or CRP levels was observed. Post hoc analyses indicated that there was a significant fall in ERI for patients with the highest baseline ESA resistance dialysed with the VE (9.28 [7.70-12.5] versus 7.70 [5.34-12.7] IU/week/kg/g/dL Hb, P = 0.01) but not the control membranes (9.45 [7.62-12.3] versus 8.14 [4.44-15.6] IU/week/kg/g/dL Hb, P = 0.41); this was not attributable to changes in CRP levels.

Conclusions: Wholesale switching of all chronic HD patients to dialysis with VE-bonded polysulfone membranes appears not to be associated with improvements in ESA-responsiveness or CRP. These membranes may have utility in patients with heightened ESA resistance.

Keywords: anaemia; haemodialysis; inflammation; vitamin E.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • C-Reactive Protein / metabolism
  • Darbepoetin alfa
  • Drug Resistance
  • Erythropoietin / analogs & derivatives*
  • Erythropoietin / therapeutic use
  • Female
  • Hematinics / therapeutic use*
  • Humans
  • Kidney Failure, Chronic / therapy*
  • Male
  • Membranes, Artificial
  • Middle Aged
  • Polymers / chemistry*
  • Prospective Studies
  • Renal Dialysis*
  • Sulfones / chemistry*
  • Vitamin E / chemistry

Substances

  • Hematinics
  • Membranes, Artificial
  • Polymers
  • Sulfones
  • Erythropoietin
  • Vitamin E
  • Darbepoetin alfa
  • polysulfone P 1700
  • C-Reactive Protein