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

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

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.

Study Overview

• Status: Completed
• Conditions: Continuous Ambulatory Peritoneal Dialysis
• Intervention / Treatment: Device: Stay Safe (STS); Device: Stay Safe Link (SSL)

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Penang
    • George Town, Penang, Malaysia, 10990
      • Clinical Research Centre, Penang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Stay Safe (STS); CAPD system produced by Fresenius Medical Care in Germany	Device: Stay Safe (STS); CAPD system produce in Germany by Fresenius Medical Care
EXPERIMENTAL: Stay Safe Link (SSL); CAPD system produced by Fresenius Medical Care in Malaysia	Device: Stay Safe Link (SSL); CAPD system produced in Malaysia by Fresenius Medical Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Penang Hospital, Malaysia
• Investigators: Principal Investigator: Loke Meng Ong, Clinical Research Centre, Penang General Hospital, Malaysia

Publications and helpful links

General Publications

• Mak WY, Ong LM, Goh BL, Bavanandan S, Mushahar L, Leong CT, Hooi LS. Protocol for a randomised, open-label, parallel group, multicentre 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. BMJ Open. 2019 Mar 8;9(3):e024589. doi: 10.1136/bmjopen-2018-024589.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2017
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): June 26, 2019

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HPP/CTP/PD/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No