Abstract: FR-PO1076
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
- Late-Breaking Clinical Trial Posters
November 03, 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 of Vienna, Vienna, Austria
- Herzog, Rebecca, Medical University of Vienna, Vienna, Austria
- Aufricht, Christoph, Medical University of Vienna, Vienna, Austria
Background
Recent meta-analyses concluded that the past 20 years development of dialysis fluids with low concentration of glucose degradation products did not lead to improved peritonitis rates, membrane failure or technique drop out of peritoneal dialysis (PD) patients. 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) and 8 weeks with AlaGln supplemented standard PD fluid (Physioneal 40 and Dipetiven [Fresenius-Kabi]), in a randomized order. As primary outcome parameters 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 at 1h (IL-6 release) and 4h (CA-125).
Results
Out of 54 enrolled PD patients in 8 Austrian centers, 50 patients were randomized. In the full analysis set (n=41), addition of AlaGln significantly increased CA-125 appearance rate (mean treatment difference: 46.7 U/min [95% CI: 23.5-69.9], p=0.0001) and log 10 of ex-vivo stimulated IL-6 release (mean treatment difference: 0.15 [95% CI: 0.04-0.26], p=0.004). Higher levels of stimulated TNFα release and lower levels of peritoneal protein loss supported the beneficial effect of intraperitoneal AlaGln supplementation. No adverse events or safety signals were observed with AlaGln, all peritonitis episodes in the safety population (n=47) occurred during standard PD fluid treatment.
Conclusion
A novel AlaGln-supplemented PD fluid improves important biomarkers of mesothelial cell status and peritoneal immune competence compared to treatment with a standard dual-chamber PD fluid.
Funding
- Commercial Support –