Newly Developed Neutralized pH Icodextrin Dialysis Fluid: Nonclinical Evaluation

Area of Science:

• Biomaterials Science
• Nephrology
• Peritoneal Dialysis

Background:

• Icodextrin peritoneal dialysis fluid (PDF) is used for fluid management in patients undergoing peritoneal dialysis.
• Icodextrin PDFs can generate glucose degradation products (GDPs) and have a low pH, potentially affecting biocompatibility.
• A novel two-compartment system, NICOPELIQ (NICO), has been developed to neutralize icodextrin PDF.

Purpose of the Study:

• To conduct a nonclinical evaluation of the NICOPELIQ system for neutralizing icodextrin PDF.
• To assess the biocompatibility and water transport ability of neutralized icodextrin PDF.
• To analyze glucose degradation products (GDPs) and their impact on cell viability and cytotoxicity.

Main Methods:

• Analysis of GDPs in icodextrin PDFs using high-performance liquid chromatography (HPLC).
• Evaluation of human peritoneal mesothelial cell (PDE-HPMC) viability and lactate dehydrogenase (LDH) release after exposure to different PDFs (NICO, EXTRANEAL [EX], MIDPELIQ 250 [M250]).
• Assessment of water transport ability using dialysis membranes with varying pore sizes.

Main Results:

• Cell viability decreased by 30% after 30 min exposure to NICO but was maintained for 6 hours, unlike EXTRANEAL.
• No significant difference in cell viability was observed between NICO and EXTRANEAL when pH was adjusted, despite higher GDPs in EXTRANEAL.
• Reduced cell viability occurred below pH 6; LDH release was minimal (<5%) with NICO exposure. Water transport was comparable between NICO and EXTRANEAL.

Conclusions:

• Neutralization of icodextrin PDF using the NICOPELIQ system is beneficial for enhancing biocompatibility.
• The NICO system effectively maintains cell viability and minimizes cytotoxicity (LDH release).
• Neutralized icodextrin PDF demonstrates comparable water transport ability to conventional icodextrin PDF.