NCT03177031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

June 13, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

May 31, 2017

Last Update Submit

October 1, 2019

Conditions

Continuous Ambulatory Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Peritonitis Rate of Stay Safe Link system

    1 year

Secondary Outcomes (6)

  • Dialysis dose delivered

    1 year

  • Dialysis dose delivered

    1 year

  • Ultrafiltration volume

    1 year

  • Product deficiencies of the PD system

    1 year

  • Product deficiencies of the PD system

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Stay Safe (STS)

ACTIVE COMPARATOR

CAPD system produced by Fresenius Medical Care in Germany

Device: Stay Safe (STS)

Stay Safe Link (SSL)

EXPERIMENTAL

CAPD system produced by Fresenius Medical Care in Malaysia

Device: Stay Safe Link (SSL)

Interventions

Stay Safe Link (SSL)DEVICE

CAPD system produced in Malaysia by Fresenius Medical Care

Stay Safe Link (SSL)
Stay Safe (STS)DEVICE

CAPD system produce in Germany by Fresenius Medical Care

Stay Safe (STS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or above
  • End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 30852538DERIVED

Study Officials

  • Loke Meng Ong

    Clinical Research Centre, Penang General Hospital, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 6, 2017

Study Start

June 13, 2017

Primary Completion

April 30, 2019

Study Completion

June 26, 2019

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data with other researchers

Locations

MY(1)