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A randomized controlled trial of alanyl-glutamine supplementation in peritoneal dialysis fluid to assess impact on biomarkers of peritoneal health
Author(s) -
Andreas Vychytil,
Rebecca Herzog,
Paul Probst,
Werner Ribitsch,
Karl Lhotta,
Veronika Machold-Fabrizii,
Martin Wiesholzer,
Michaela Kaufmann,
H. Peter Soyer,
Martin Windpessl,
Alexander R. Rosenkranz,
Rainer Oberbauer,
Franz König,
Klaus Kratochwill,
Christoph Aufricht
Publication year - 2018
Publication title -
kidney international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.499
H-Index - 276
eISSN - 1523-1755
pISSN - 0085-2538
DOI - 10.1016/j.kint.2018.08.031
Subject(s) - medicine , peritoneal dialysis , peritoneal fluid , ex vivo , crossover study , peritoneal equilibration test , peritonitis , gastroenterology , randomized controlled trial , ascites , placebo , glutamine , in vivo , pathology , continuous ambulatory peritoneal dialysis , biochemistry , chemistry , alternative medicine , microbiology and biotechnology , amino acid , biology
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.

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