Renal FailurePhase 4NCT00966615
The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition
A Phase 4 study testing double-chamber bag Stay-Safe Balance system and glucose-based dialysis solution in people with Renal Failure and ESRD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, ESRD, Cardiovascular Disease
- What is being tested?
- double-chamber bag Stay-Safe Balance system and glucose-based dialysis solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2010to Sep 2014
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new adult continuous ambulatory peritoneal dialysis (CAPD) patients, both diabetic and non-diabetic
Who cannot join
- unlikely to survive, planned to have elective living-related kidney transplant, or transfer to other renal center within 6 months
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin
About this study
Official title: The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial
Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.
Read the detailed description
(see above)
- Conditions
- Renal Failure, ESRD, Cardiovascular Disease
- Being tested
- double-chamber bag Stay-Safe Balance system, glucose-based dialysis solution
- Keywords
- malnutrition, fluid status, survival
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Cardiovascular Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double-chamber bag Stay-Safe Balance systemOther
Also called Stay-Safe Balance system
2-L exchange; three times a day
glucose-based dialysis solutionOther
Also called Stay-Safe, Fresenius
2-L exchange; three times a day
| Study group | Role | What they receive |
|---|---|---|
| Balance group | Experimental | peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product Receives: Other: double-chamber bag Stay-Safe Balance system |
| Control group | Active comparator | conventional PD solution Receives: Other: glucose-based dialysis solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition
Measured: 52 weeks
arterial pulse wave velocity
Measured: 52 weeks
Secondary outcomes (5)
nutritional and adequacy indices
Measured: 52 weeks
peritoneal transport characteristics
Measured: 52 weeks
residual renal function
Measured: 52 weeks
peritonitis-free survival, actuarial and technique survival
Measured: 52 weeks
hospitalization
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionSep 2014
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 Renal FailureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheuk-Chun SZETO, Chinese University of Hong Kong
- Investigators
- Cheuk Chun Szeto, MD, Principal investigator, Chinese University of Hong KongPhilip KT Li, MD, Study director, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966615
- Sponsor's protocol ID
- Balance BCM
- Status last verified
- Sep 2014
- First submitted
- 26 Aug 2009
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Szeto CC, Kwan BC, Chow KM, Cheng PM, Kwong VW, Choy AS, Law MC, Leung CB, Li PK. The Effect of Neutral Peritoneal Dialysis Solution with Low Glucose-Degradation-Product on the Fluid Status and Body Composition--A Randomized Control Trial. PLoS One. 2015 Oct 28;10(10):e0141425. doi: 10.1371/journal.pone.0141425. eCollection 2015.
PubMed 26510186
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00966615
- Acronym / sponsor ID
- Balance BCM
- Conditions
- Renal Failure, ESRD, Cardiovascular Disease
- Keywords
- malnutrition, fluid status, survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Aug 2009 (estimated)
- 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.
Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.
Detailed description
(see above)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance group | Experimental | Other: double-chamber bag Stay-Safe Balance systemperitoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product |
| Control group | Active comparator | Other: glucose-based dialysis solutionconventional PD solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- new adult continuous ambulatory peritoneal dialysis (CAPD) patients, both diabetic and non-diabetic
Key exclusion criteria (1 listed)
- unlikely to survive, planned to have elective living-related kidney transplant, or transfer to other renal center within 6 months
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 |
|---|---|---|
| double-chamber bag Stay-Safe Balance systemAlso: Stay-Safe Balance system2-L exchange; three times a day | Other | Balance group |
| glucose-based dialysis solutionAlso: Stay-Safe, Fresenius2-L exchange; three times a day | Other | Control group |
Primary outcome
body composition
Time frame: 52 weeks
arterial pulse wave velocity
Time frame: 52 weeks
5 secondary outcomes
nutritional and adequacy indices
Time frame: 52 weeks
peritoneal transport characteristics
Time frame: 52 weeks
residual renal function
Time frame: 52 weeks
peritonitis-free survival, actuarial and technique survival
Time frame: 52 weeks
hospitalization
Time frame: 52 weeks
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 8 Sep 2014.
- Derived from this study: PubMed 26510186Szeto CC, Kwan BC, Chow KM, Cheng PM, Kwong VW, Choy AS, Law MC, Leung CB, Li PK. The Effect of Neutral Peritoneal Dialysis Solution with Low Glucose-Degradation-Product on the Fluid Status and Body Composition--A Randomized Control Trial. PLoS One. 2015 Oct 28;10(10):e0141425. doi: 10.1371/journal.pone.0141425. eCollection 2015.
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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.
Cheuk Chun Szeto, MD principal investigator
Chinese University of Hong Kong
Philip KT Li, MD study director
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing double-chamber bag Stay-Safe Balance system and glucose-based dialysis solution in people with Renal Failure and ESRD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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 8 Sep 2014. 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 Hong Kong. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
body composition (time frame: 52 weeks). The study lists 2 primary outcomes in all. 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 NCT00966615, 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 8 Sep 2014.