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

Not Applicable

Completed

• Conditions: Continuous Ambulatory Peritoneal Dialysis
• Interventions: Device: Stay Safe (STS); Device: Stay Safe Link (SSL)

• 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

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Study Start: 2017-06-13
• Primary Completion: 2019-04-30
• Study Completion: 2019-06-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

1. 18 years of age or above
2. End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
3. Written informed consent

Exclusion Criteria

1. Requirement for 2.5L exchanges
2. Requirement for Stay Safe Balance®
3. PD-related infection (peritonitis, exit site or tunnel tract infection) in the preceding 8 weeks or during conversion
4. Malfunctioning of PD catheter
5. Planned transfer to automated peritoneal dialysis, haemodialysis or transplant within 90 days
6. Pregnancy
7. Any condition that compromises the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function
8. History of active alcohol or substance abuse in the previous 6 months
9. 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

Arm && Interventions

Group	Intervention	Description
Stay Safe (STS)	Stay Safe (STS)	CAPD system produced by Fresenius Medical Care in Germany
Stay Safe Link (SSL)	Stay Safe Link (SSL)	CAPD system produced by Fresenius Medical Care in Malaysia

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)

Trial Locations

Locations (1)

Clinical Research Centre, Penang Hospital; 🇲🇾 George Town, Penang, Malaysia