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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)
NA trial testing Stay Safe Link (SSL) in Continuous Ambulatory Peritoneal Dialysis in 472 participants. Completed in 26 June 2019.
30 April 2019
Quick facts
| Lead sponsor | Penang Hospital, Malaysia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 472 |
| Start date | 13 June 2017 |
| Primary completion | 30 April 2019 |
| Estimated completion | 26 June 2019 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Stay Safe Link (SSL)
- Stay Safe (STS)
Conditions studied
- Continuous Ambulatory Peritoneal Dialysis — all drugs for Continuous Ambulatory Peritoneal Dialysis →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03177031
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Penang Hospital, Malaysia trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03177031 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Penang Hospital, Malaysia
- Last refreshed: 3 October 2019
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing