[Translation] A multicenter, randomized, open-label, reference-controlled clinical trial evaluating the safety and efficacy of icodextrin peritoneal dialysis solution for daily single-dose, long-duration inpatient peritoneal dialysis in patients with end-stage renal disease.
评价艾考糊精腹膜透析液受试制剂和参比制剂用于终末期肾病患者持续性不卧床腹膜透析每日单次长时间留腹治疗的有效性和安全性,以评价两种制剂的临床等效性。
[Translation] To evaluate the efficacy and safety of the test and reference formulations of icodextrin peritoneal dialysis solution for single-day, long-duration, continuous ambulatory peritoneal dialysis in patients with end-stage renal disease, and to assess the clinical equivalence of the two formulations.