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

Continuous Ambulatory Peritoneal Dialysis Clinical Trial

— CAPD-3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177031
• Other study ID #: HPP/CTP/PD/003
• Status: Completed
• Phase: N/A
• Start date: June 13, 2017
• Est. completion date: June 26, 2019

Study information

• Verified date: October 2019
• Source: Penang Hospital, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: June 26, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Continuous Ambulatory Peritoneal Dialysis

Intervention

Device:
• Stay Safe Link (SSL)
CAPD system produced in Malaysia by Fresenius Medical Care
• Stay Safe (STS)
CAPD system produce in Germany by Fresenius Medical Care

Locations

Country	Name	City	State
Malaysia	Clinical Research Centre, Penang Hospital	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritonitis Rate of Stay Safe Link system		1 year
Secondary	Dialysis dose delivered	weekly Kt/V	1 year
Secondary	Dialysis dose delivered	creatinine clearance (L)	1 year
Secondary	Ultrafiltration volume	Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg)	1 year
Secondary	Product deficiencies of the PD system	Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected)	1 year
Secondary	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
Secondary	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