NCT03177031

Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Penang Hospital, Malaysia · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Continuous Ambulatory Peritoneal Dialysis

Interventions

Type	Name	Description
DEVICE	Stay Safe Link (SSL)	CAPD system produced in Malaysia by Fresenius Medical Care
DEVICE	Stay Safe (STS)	CAPD system produce in Germany by Fresenius Medical Care

Timeline

• Start date: 2017-06-13
• Primary completion: 2019-04-30
• Completion: 2019-06-26
• First posted: 2017-06-06
• Last updated: 2019-10-03

Locations

1 site across 1 country: Malaysia