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

Penang Hospital, Malaysia

Status

Completed

Conditions

Continuous Ambulatory Peritoneal Dialysis

Treatments

Device: Stay Safe (STS)

Device: Stay Safe Link (SSL)

Study type

Interventional

Funder types

Other

Identifiers

NCT03177031

HPP/CTP/PD/003

Details and patient eligibility

About

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.

Enrollment

472 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Pregnancy
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