A randomized controlled trial of alanyl-glutamine supplementation in peritoneal dialysis fluid to assess impact on biomarkers of peritoneal health

Andreas Vychytil, Rebecca Herzog, Paul Probst, Werner Ribitsch, Karl Lhotta, Veronika Machold-Fabrizii, Martin Wiesholzer, Michaela Kaufmann, Hermann Salmhofer, Martin Windpessl, Alexander R Rosenkranz, Rainer Oberbauer, Franz König, Klaus Kratochwill, Christoph Aufricht

Research output: Journal article (peer-reviewed)Journal article

Abstract

In early clinical testing, acute addition of alanyl-glutamine (AlaGln) to glucose-based peritoneal dialysis (PD) fluids restored peritoneal cellular stress responses and leukocyte function. This study was designed to test the effect of extended treatment with AlaGln-supplemented PD fluid on biomarkers of peritoneal health. In a double-blinded, randomized crossover design, stable PD patients were treated with AlaGln (8 mM) or placebo added to PD fluid for eight weeks. As primary outcome measures, dialysate cancer-antigen 125 (CA-125) appearance rate and ex vivo stimulated interleukin-6 (IL-6) release were assessed in peritoneal equilibration tests. In 8 Austrian centers, 54 patients were screened, 50 randomized, and 41 included in the full analysis set. AlaGln supplementation significantly increased CA-125 appearance rate and ex vivo stimulated IL-6 release. AlaGln supplementation also reduced peritoneal protein loss, increased ex vivo stimulated tumor necrosis factor (TNF)-α release, and reduced systemic IL-8 levels. No adverse safety signals were observed. All 4 peritonitis episodes occurred during standard PD fluid treatment. A novel AlaGln-supplemented PD fluid improves biomarkers of peritoneal membrane integrity, immune competence, and systemic inflammation compared to unsupplemented PD fluid with neutral pH and low-glucose degradation. A phase 3 trial is needed to determine the impact of AlaGln supplementation on hard clinical outcomes.

Original languageEnglish
Pages (from-to)1227-1237
Number of pages11
JournalKidney International
Volume94
Issue number6
DOIs
Publication statusPublished - Dec 2018

Keywords

  • Aged
  • Austria
  • Biomarkers/analysis
  • Cross-Over Studies
  • Dialysis Solutions/chemistry
  • Dipeptides/administration & dosage
  • Female
  • Humans
  • Kidney Failure, Chronic/therapy
  • Male
  • Middle Aged
  • Peritoneal Dialysis/adverse effects
  • Peritoneum/drug effects
  • Peritonitis/diagnosis
  • Proof of Concept Study
  • Prospective Studies
  • Treatment Outcome

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