Clinical trial NCT03177031: Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Ambulatory Peritoneal Dialysis
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
First posted: 2017-06-06
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peritonitis Rate of Stay Safe Link system
timeFrame: 1 year
Secondary outcomes:
measure: Dialysis dose delivered
timeFrame: 1 year
measure: Dialysis dose delivered
timeFrame: 1 year
measure: Ultrafiltration volume
timeFrame: 1 year
measure: Product deficiencies of the PD system
timeFrame: 1 year
measure: Product deficiencies of the PD system
timeFrame: 1 year
measure: Safety Assessment of the PD system
timeFrame: 1 year
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Clinical Research Centre, Penang Hospital
state: Penang
Study officials:
affiliation: Clinical Research Centre, Penang General Hospital, Malaysia
name: Loke Meng Ong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.