Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)
- Conditions
- Continuous Ambulatory Peritoneal Dialysis
- Registration Number
- NCT03177031
- Lead Sponsor
- Penang Hospital, Malaysia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 472
- 18 years of age or above
- End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Peritonitis Rate of Stay Safe Link system 1 year
- Secondary Outcome Measures
Name Time Method Dialysis dose delivered 1 year creatinine clearance (L)
Product deficiencies of the PD system 1 year Bacterial or other contamination of dialysate or any component of the PD system (number of contamination detected)
Safety Assessment of the PD system 1 year Technique failure, defined as the transfer to hemodialysis for more than 30 days (number of technique failure detected)
Ultrafiltration volume 1 year Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg)
Related Research Topics
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Trial Locations
- Locations (1)
Clinical Research Centre, Penang Hospital
🇲🇾George Town, Penang, Malaysia
Clinical Research Centre, Penang Hospital🇲🇾George Town, Penang, Malaysia