A new peritoneal dialysis fluid for Japan: A randomized non-inferiority clinical trial of safety and efficacy

Phase 3

Completed

• Conditions: Chronic renal failure; Urological and Genital Diseases

• Registration Number: ISRCTN48112900
• Lead Sponsor: Baxter Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-04-15
• Study Start: 2016-03-08
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peritoneal creatinine clearance and ultrafiltration volume are measured using blood and dialysis effluent analysis at baseline, 4, 8 and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Peritoasuneal urea clearance is measured using blood and dialysis effluent analysis at baseline, 4, 8 and 12 weeks<br>2. Electrolyte (Na, K, Cl, Ca, Mg, P) concentration is measured using blood analysis at baseline, 4, 8 and 12 weeks<br>3. Plasma bicarbonate concentration is measured using blood analysis at baseline, 4, 8 and 12 weeks