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NCT03177031: CAPD-3

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

Completed NA Last updated 3 October 2019
What this trial tests

NA trial testing Stay Safe Link (SSL) in Continuous Ambulatory Peritoneal Dialysis in 472 participants. Completed in 26 June 2019.

Timeline
13 June 2017
Primary endpoint
30 April 2019
26 June 2019

Quick facts

Lead sponsorPenang Hospital, Malaysia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment472
Start date13 June 2017
Primary completion30 April 2019
Estimated completion26 June 2019
Sites1 location across Malaysia

Drugs / interventions tested

Conditions studied

Sponsor

Penang Hospital, Malaysia

Who can join

18 and older, any sex, with Continuous Ambulatory Peritoneal Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Mak WY, Ong LM, Goh BL, Bavanandan S, et al · · 2019 · PMID 30852538 · DOI 10.1136/bmjopen-2018-024589

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Other Penang Hospital, Malaysia trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03177031.

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