Performance Evaluation of an Automated Peritoneal Dialysis Solution Generation System in Patients Using Automated Peritoneal Dialysis.

Introduction: Most patients on peritoneal dialysis (PD) in the United States are on automated PD (APD) utilizing several liters of PD solution daily for their treatment. The ordering, delivery, and storage of PD solutions can be challenging and is an important factor that can dissuade patients from doing PD. The generation of PD solutions at home is a strategy that could potentially be used to overcome this problem. The APD Solution Generation System (SGS) allowed for PD solution generation using tap water in patients' homes. Methods: In this study, we set out to evaluate the performance of the SGS in prevalent, adult patients with end-stage kidney disease, who are on maintenance PD. We evaluated the primary safety (microbiological testing) and efficacy (chemical composition) of the product water generated by the SGS device. Results: Twenty-two patients from 12 different United States centers were enrolled, of which 14 patients completed the study. The results of the primary safety and efficacy end point analyses of the product water showed that all 64 samples met the International Organization for Standardization (ISO) specifications. Secondary safety analysis found a total of 34 adverse events (AEs) in 12 patients. Of these AEs, 3, namely, culture negative peritonitis, bacterial peritonitis, and atrial fibrillation were deemed serious treatment-emergent AEs. Conclusion: This study demonstrated that the SGS can successfully generate PD solution in patients' homes, while meeting chemical composition and ISO microbiological standards. Lessons learned from this clinical trial will be useful in optimizing product development and future clinical trials.

Pharmacokinetic and pharmacodynamic bioequivalence between regular human insulin (rDNA origin) in 0.9% sodium chloride ready-to-use infusion 1 U/mL and 100 U/mL concentrate diluted to 1 U/mL in healthy males.

AIM: To show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence between Myxredlin, a novel, ready-to-use regular human insulin 1 U/mL formulation (BAX-HI), and Novolin R 100 U/mL concentrate diluted to 1 U/mL (NOVO-HI). MATERIALS AND METHODS: This phase 1, double-blind, randomized, two-way crossover study compared the PK and PD properties of BAX-HI and NOVO-HI. A total of 58 healthy males received 0.36 U/kg of each study drug, administered intravenously over a 6-hour period, concurrent with an 8-hour euglycaemic clamp at two treatment periods separated by a washout period of 7-10 days. The primary PK endpoint was the area under the insulin concentration-time curve at steady state (SS) measured from 300 to 360 minutes (AUCINS-SS 300-360 min ). The primary PD endpoint was the area under the glucose infusion rate-time curve at SS measured from 300 to 360 minutes (AUCGIR-SS 300-360 min ). RESULTS: All subjects completed the first treatment period and 54 subjects completed both treatment periods. Bioequivalence between BAX-HI and NOVO-HI was shown for the primary endpoints as the 90% confidence interval (CI) of the geometric least-squares (LS) mean ratio for AUCINS-SS 300-360 min , and the 90% CI and 95% CI of the geometric LS mean ratio for AUCGIR-SS 300-360 min were entirely contained within the prespecified limits of 80%-125%. Safety profiles were comparable for both study drugs and there were no serious adverse events. CONCLUSIONS: The study showed bioequivalence between BAX-HI and NOVO-HI in terms of PK and PD characteristics in healthy males.