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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Continuous Ambulatory Peritoneal Dialysis

Intervention / Treatment
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* Device: Stay Safe Link (SSL)
* Device: Stay Safe (STS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stay Safe (STS)<br>CAPD system produced by Fresenius Medical Care in Germany | Device: Stay Safe (STS)<br>* CAPD system produce in Germany by Fresenius Medical Care<br>|
| Experimental: Stay Safe Link (SSL)<br>CAPD system produced by Fresenius Medical Care in Malaysia | Device: Stay Safe Link (SSL)<br>* CAPD system produced in Malaysia by Fresenius Medical Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritonitis Rate of Stay Safe Link system |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis dose delivered | weekly Kt/V | 1 year | 
| Dialysis dose delivered | creatinine clearance (L) | 1 year | 
| Ultrafiltration volume | Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg) | 1 year | 
| Product deficiencies of the PD system | Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected) | 1 year | 
| Product deficiencies of the PD system | Bacterial or other contamination of dialysate or any component of the PD system (number of contamination detected) | 1 year | 
| Safety Assessment of the PD system | Technique failure, defined as the transfer to hemodialysis for more than 30 days (number of technique failure detected) | 1 year |