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Completed

NCT Number: NCT03177031

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

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.

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Key information

Conditions

Continuous Ambulatory Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stay Safe Link (SSL)

Device

CAPD system produced in Malaysia by Fresenius Medical Care

Stay Safe (STS)

Device

CAPD system produce in Germany by Fresenius Medical Care

Primary outcomes

  1. Peritonitis Rate of Stay Safe Link system

    Time frame: 1 year

Secondary outcomes

  1. Dialysis dose delivered

    Time frame: 1 year

    weekly Kt/V

  2. Dialysis dose delivered

    Time frame: 1 year

    creatinine clearance (L)

  3. Ultrafiltration volume

    Time frame: 1 year

    Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg)

  4. Product deficiencies of the PD system

    Time frame: 1 year

    Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected)

  5. Product deficiencies of the PD system

    Time frame: 1 year

    Bacterial or other contamination of dialysate or any component of the PD system (number of contamination detected)

  6. Safety Assessment of the PD system

    Time frame: 1 year

    Technique failure, defined as the transfer to hemodialysis for more than 30 days (number of technique failure detected)

Sponsors and collaborators

Lead sponsor

Penang Hospital, Malaysia

Other Gov

Registry information

Official study 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

Acronym: CAPD-3

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2017
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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