Abstract
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.