A randomized parallel-group comparative study to verify efficacy (non-inferiority) of BLR350 using Dianeal PD-2 as a comparator in patients with chronic renal failure receiving CAPD (Continuous Ambulatory Peritoneal Dialysis)

Baxter Limited0 个研究点目标入组 113 人开始时间: 2016年3月8日最近更新: 2023年5月8日

适应症

试验速览

2016 Results article in https://pubmed.ncbi.nlm.nih.gov/27783275/ (added 25/04/2023)

•1. Patients that have been continuously undergoing CAPD therapy for at least 3 months before the start of the baseline period
•2. Patients that have been continuously using solely 2 L of Dianeal PD-2 for at least 4 weeks before the start of the baseline period
•3. Patients that have given written consent to participate in this study
•4. Patients that are aged over20 years at the time of giving consent
•5. Either male or female patients may be enrolled, and either inpatients or outpatients may be enrolled

•1. Patients that have a tunnel infection or a severe exit-site infection and are likely to develop peritonitis
•2. Patients that have developed peritonitis or have not recovered from peritonitis within 4 weeks before the start of the baseline period
•3. Patients with a serious disease other than chronic renal failure (e.g., malignant tumor, hepatic cirrhosis, active hepatitis, chronic heart failure, systemic infection, significant malnutrition, significant peritoneal membrane dysfunction, negative ultrafiltration and likely to convert to hemodialysis)
•4. Patients that have participated in another clinical study within 6 months before obtaining consent
•5. Patients that are pregnant, lactating or may be pregnant
•6. In addition, patients that have been judged to be ineligible to participate in this study by the investigator/sub-investigator

发起方

Baxter Limited