Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)
NCT ID: NCT03177031
Last Updated: 2019-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
472 participants
INTERVENTIONAL
2017-06-13
2019-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open Label Trial to Establish the Equivalence Between ANDY-Disc® and Ultrabag® in Patients on CAPD.
NCT00255619
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
NCT01637792
Randomized Controlled Trial on 3D Printed Assistive Device for Continuous Ambulatory Peritoneal Dialysis
NCT05521425
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
NCT01753154
A Feasibility Study of Peritoneal Dialysis With CLS PD, Which Removes Toxins and Maintains a Stable Ultrafiltration by Continuously Regenerating a Recirculating Intraperitoneal Fluid, in Patients With End Stage Renal Disease, ESRD, With PD Therapy.
NCT03190018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stay Safe (STS)
CAPD system produced by Fresenius Medical Care in Germany
Stay Safe (STS)
CAPD system produce in Germany by Fresenius Medical Care
Stay Safe Link (SSL)
CAPD system produced by Fresenius Medical Care in Malaysia
Stay Safe Link (SSL)
CAPD system produced in Malaysia by Fresenius Medical Care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stay Safe Link (SSL)
CAPD system produced in Malaysia by Fresenius Medical Care
Stay Safe (STS)
CAPD system produce in Germany by Fresenius Medical Care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
3. Written informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Penang Hospital, Malaysia
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Loke Meng Ong
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Centre, Penang General Hospital, Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Centre, Penang Hospital
George Town, Pulau Pinang, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HPP/CTP/PD/003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.