PHASE III STUDY
605 patients months on Physioneal in Phase III
Physioneal was shown to be therapeutically equivalent to Dianeal PD4 with regard to the primary efficacy parameter, plasma bicarbonate, as well as to the secondary parameters, peritoneal urea and creatinine clearance and 24 hour peritoneal ultrafiltration
There were no major safety issues in either group, with both showing similar patterns of adverse events and out of range laboratory results.
Patients reported less pain on infusion when using the bicarbonate/lactate bags.
Physioneal is safe and effective.