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

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.

journal_name

Kidney Int

journal_title

Kidney international

authors

Vychytil A,Herzog R,Probst P,Ribitsch W,Lhotta K,Machold-Fabrizii V,Wiesholzer M,Kaufmann M,Salmhofer H,Windpessl M,Rosenkranz AR,Oberbauer R,König F,Kratochwill K,Aufricht C

doi

10.1016/j.kint.2018.08.031

subject

Has Abstract

pub_date

2018-12-01 00:00:00

pages

1227-1237

issue

6

eissn

0085-2538

issn

1523-1755

pii

S0085-2538(18)30637-9

journal_volume

94

pub_type

杂志文章,多中心研究,随机对照试验

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