Continuous Ambulatory Peritoneal DialysisCAPD-3NCT03177031
Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)
A study testing Stay Safe Link (SSL) and Stay Safe (STS) in people with Continuous Ambulatory Peritoneal Dialysis, run by Penang Hospital, Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Ambulatory Peritoneal Dialysis
- What is being tested?
- Stay Safe Link (SSL) and Stay Safe (STS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Jun 2017to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or above
- End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
- Written informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Clinical Research Centre, Penang Hospital
George Town, Pulau Pinang, 10990
About this study
Official 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
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.
- Being tested
- Stay Safe Link (SSL), Stay Safe (STS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Stay Safe (STS) | Active comparator | CAPD system produced by Fresenius Medical Care in Germany Receives: Device: Stay Safe (STS) |
| Stay Safe Link (SSL) | Experimental | CAPD system produced by Fresenius Medical Care in Malaysia Receives: Device: Stay Safe Link (SSL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritonitis Rate of Stay Safe Link system
Measured: 1 year
Secondary outcomes (6)
Dialysis dose delivered
weekly Kt/V
Measured: 1 year
Dialysis dose delivered
creatinine clearance (L)
Measured: 1 year
Ultrafiltration volume
Post-PD bodyweight (kg) minus Pre-PD bodyweight (kg)
Measured: 1 year
Product deficiencies of the PD system
Defect or leakages of PD bags, tubing or organiser (number of defects or leakages detected)
Measured: 1 year
Product deficiencies of the PD system
Bacterial or other contamination of dialysate or any component of the PD system (number of contamination detected)
Measured: 1 year
Safety Assessment of the PD system
Technique failure, defined as the transfer to hemodialysis for more than 30 days (number of technique failure detected)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start13 Jun 2017
- Primary completion30 Apr 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuous Ambulatory Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Loke Meng Ong, Principal investigator, Clinical Research Centre, Penang General Hospital, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177031
- Sponsor's protocol ID
- HPP/CTP/PD/003
- Acronym
- CAPD-3
- Status last verified
- Oct 2019
- First submitted
- 31 May 2017
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers
Publications
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.
PubMed 30852538
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03177031
- Acronym / sponsor ID
- CAPD-3 / HPP/CTP/PD/003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stay Safe (STS) | Active comparator | Device: Stay Safe (STS)CAPD system produced by Fresenius Medical Care in Germany |
| Stay Safe Link (SSL) | Experimental | Device: Stay Safe Link (SSL)CAPD system produced by Fresenius Medical Care in Malaysia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or above
- End stage kidney failure receiving Stay Safe® PD system for at least 4 weeks
- Written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stay Safe Link (SSL)CAPD system produced in Malaysia by Fresenius Medical Care | Device | Stay Safe Link (SSL) |
| Stay Safe (STS)CAPD system produce in Germany by Fresenius Medical Care | Device | Stay Safe (STS) |
Primary outcome
Peritonitis Rate of Stay Safe Link system
Time frame: 1 year
6 secondary outcomes
Dialysis dose delivered
Time frame: 1 year
Dialysis dose delivered
Time frame: 1 year
Ultrafiltration volume
Time frame: 1 year
Product deficiencies of the PD system
Time frame: 1 year
Product deficiencies of the PD system
Time frame: 1 year
Safety Assessment of the PD system
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 30852538Mak 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers
Related trials for Continuous Ambulatory Peritoneal Dialysis
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
Recruiting
Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Children With End-stage Kidney Disease From Low-resource Settings
Children on Chronic Peritoneal Dialysis
RecruitingObservational study
Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
End-stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loke Meng Ong principal investigator
Clinical Research Centre, Penang General Hospital, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stay Safe Link (SSL) and Stay Safe (STS) in people with Continuous Ambulatory Peritoneal Dialysis, run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritonitis Rate of Stay Safe Link system (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.