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Abstract: SA-PO730

Prospective, Randomized, Multi-Center, Double-Blind, Controlled, Two-Period, Two-Treatment, Crossover, Phase II Trial to Evaluate the Safety and Efficacy of Alanyl-Glutamine in Peritoneal Dialysis

Session Information

  • Peritoneal Dialysis - II
    November 04, 2017 | Location: Hall H, Morial Convention Center
    Abstract Time: 10:00 AM - 10:00 AM

Category: Dialysis

  • 608 Peritoneal Dialysis

Authors

  • Vychytil, Andreas, Medical University of Vienna, Vienna, Austria
  • Kratochwill, Klaus, Medical University Vienna, Vienna, Austria
  • Herzog, Rebecca, Medical University Vienna, Vienna, Austria
  • Aufricht, Christoph, Medical University Vienna, Vienna, Austria
Background

Peritonitis and membrane failure remain serious complications of peritoneal dialysis (PD). In early clinical testing, addition of alanyl-glutamine (AlaGln) to a single dwell of glucose-based PD fluids restored peritoneal cellular stress responses and leukocyte function. This study tests effects of a novel AlaGln supplemented PD fluid on relevant biomarkers in a nation-wide trial.

Methods

In a prospective, double-blinded, cross-over design (EudraCT-2013-000400-42) stable PD outpatients were enrolled to undergo 16 weeks of treatment, 8 weeks with standard PD fluid (Physioneal 40, Baxter, US) and 8 weeks with AlaGln supplemented standard PD fluid (Physioneal 40 and Dipetiven (Fresenius-Kabi, Bad Homburg, Germany) in a randomized order. Cancer-antigen 125 (CA-125) appearance rate as marker of peritoneal cell mass and ex-vivo stimulated interleukin 6 (IL-6) release as marker of peritoneal immune competence were assessed in effluents of standard peritoneal equilibration tests (PET) at 1 h (IL-6 release) and 4 h (CA-125). Secondary outcome parameters were peritoneal and systemic markers of inflammation, amino acid metabolism and transport kinetics.

Results

Out of 54 enrolled PD patients in eight Austrian centers, 50 patients were randomized. In the full analysis set (n=41), addition of AlaGln met both primary outcome parameters with significantly increased CA-125 appearance rate and ex-vivo stimulated IL-6 release. No adverse events or safety signals were observed with PD fluid with added AlaGln, all peritonitis episodes in the safety population (n=47) occurred in the control group with standard PD fluid treatment.

Conclusion

We conclude that a novel AlaGln-supplemented glucose-based PD fluid improves biomarkers of mesothelial cell status and peritoneal immune competence compared to treatment with a standard dual-chamber PD fluid. Future clinical trials are needed to translate these findings into reduction of major PD-related clinical adverse events.

Funding

  • Commercial Support