A Randomised, Open-label, Parallel Group, Multi-centre Controlled Study to Evaluate the Clinical Performance and Safety of Stay Safe Link® Compared With Stay Safe® in Patients With End-stage Kidney Disease on Continuous Ambulatory Peritoneal Dialysis

Penang Hospital, Malaysia1 site in 1 country472 target enrollmentJune 13, 2017

ConditionsContinuous Ambulatory Peritoneal Dialysis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Continuous Ambulatory Peritoneal Dialysis
Sponsor: Penang Hospital, Malaysia
Enrollment: 472
Locations: 1
Primary Endpoint: Peritonitis Rate of Stay Safe Link system
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This post-marketing study is undertaken to compare the clinical effectiveness and safety of two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e. Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is produced in Malaysia. The study is an open labelled, randomised controlled trial where 434 patients in total will be randomised to either STS or SSL in a 1:1 ratio.

Registry

clinicaltrials.gov

Start Date

June 13, 2017

End Date

June 26, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Penang Hospital, Malaysia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or above
•End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
•Written informed consent

Exclusion Criteria

•Requirement for 2.5L exchanges
•Requirement for Stay Safe Balance®
•PD-related infection (peritonitis, exit site or tunnel tract infection) in the preceding 8 weeks or during conversion
•Malfunctioning of PD catheter
•Planned transfer to automated peritoneal dialysis, haemodialysis or transplant within 90 days
•Any condition that compromises the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function
•History of active alcohol or substance abuse in the previous 6 months
•Other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes