Chronic Renal FailurePhase 4NCT00255619
Open Label Trial to Establish the Equivalence Between ANDY-Disc® and Ultrabag® in Patients on CAPD.
A Phase 4 study testing Baxter's UltraBag® and FMC Andy·Disc® in people with Chronic Renal Failure, run by Ministry of Health, Malaysia at 6 sites in Malaysia.
Trial summary
Apart from haemodialysis, continuous ambulatory peritoneal dialysis (CAPD) is another effective therapy for end stage renal disease (ESRD). The Achilles heel of CAPD however is peritonitis, which is a major cause of morbidity and mortality in CAPD patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Baxter's UltraBag® and FMC Andy·Disc®
- Type of treatment
- Medical device
- How many people
- 264 participants
- Where
- 6 sitesMalaysia
- Study dates
- May 2002to May 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained from patient or parents/guardian.
- New or existing patients (on the single bag system) with end stage renal failure in the MOH CAPD programme with indications for using the twin bag system. For the purpose of this trial, these indications are:
- All paediatric patients (up to the age of 18 years)
- Patients who could not be trained to use the single bag system
- Existing CAPD patients on the single bag system with recurrent peritonitis
- Existing CAPD patients on the single bag system who for various reasons could no longer continue with the system.
- Existing CAPD patients on the single bag system who in the opinion of the investigator would benefit from a switch to the twin bag system.
Who cannot join
- Participation in any CAPD trial in which the patient received an investigational product within 30 days preceding the screening phase of this study.
- Those persons directly involved in the conduct of the study.
- History of non-compliance to medical regimen or patients who are unwilling or unable to comply with the protocol.
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
- Patients expected to be transferred to a non participating centre within the next six months
- Patients presently on a twin bag system
- Use of automated cycler assistance
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Malaysia6 sites
Department of Medicine, Penang Hospital
George Town, Pulau Pinang
Department of Medicine, Sultanah Aminah Hospital
Johor Bharu, Johor
Department of Nephrology, Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur
Department of Pediatrics, Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur
Department of Nephrology,Selayang Hospital
Selayang Baru Utara, Selangor
Department of Medicine, Seremban Hospital
Seremban, Negeri Sembilan
About this study
Official title: A Randomized, Multi-Center, Open Label Trial to Establish the Equivalence Between ANDY-Disc® (Fresenius Medical Care) and Ultrabag® (Baxter) in Patients on CAPD. [CAPD-2 Trial]
Apart from haemodialysis, continuous ambulatory peritoneal dialysis (CAPD) is another effective therapy for end stage renal disease (ESRD). The Achilles heel of CAPD however is peritonitis, which is a major cause of morbidity and mortality in CAPD patients. Advances in connectology, such as the disconnect system, have resulted in reduced rate of peritonitis. The disconnect system which incorporated a Y-connection allow contamination occurring at the time of connection of the system to flush into the drainage bag thereby reducing the size of microorganism innoculum entering the peritoneal cavity. In recent years, the twin bag system where both the infusion and drainage bags are pre-attached to the Y tubing, has resulted in further reduction in peritonitis rate.
Two different twin bags systems are being introduced into the MOH hospitals. They are Baxter UltraBag® and Fresenius Andy·Disc®.
Even though both the systems are very similar, our own experience suggest that minor variation in the connectology could translate into marked differences in the peritonitis rate. In this multi centre, randomised controlled study, both the twin bag systems will be evaluated to establish their equivalence with respect to the incidence of peritonitis and technique failure.
Read the detailed description
This is a multi-centre, open label, parallel group randomized trial designed to demonstrate the therapeutic equivalence of ANDY-Disc® with Ultrabag® for a treatment period of 12 months. 270 patients on CAPD from 6 participating sites who met inclusion/exclusion criteria were enrolled into the trial. After initial screening, patients attended clinic for baseline examination, including clearance studies. Subjects were then randomly allocated to ANDY-Disc® or Ultrabag® in a ratio of 1:1. Study visits occurred every 2 weeks through 4 weeks, then every 4 weeks through 12 weeks, and every 12 weeks thereafter for the duration of the study (12 months). Hence there were a total of 7 visits (1 screen/baseline, 2 biweekly, 2-4 weekly and 2-6 monthly treatment visits, the last being the final visit).
Safety and tolerability assessments consisted of monitoring adverse events and serious adverse events, monitoring of haematology, blood chemistry and regular performance of physical examinations.
Criteria for evaluation:
Efficacy: Primary efficacy parameter:The primary efficacy variable will be the incidence of peritonitis. Peritonitis is defined as the presence of at least two of the following
- Abdominal pain or tenderness
- Presence of white blood cells in peritoneal effluent in excess of 100 cells per mL composed of at least 50% polymorphs
- Positive cultureSecondary efficacy parameter:
The secondary efficacy variables are:
- Technique failure; defined as transfer to haemodialysis or death. Note that cross-over to a comparator treatment will be considered as withdrawal.
Frequency of technical problem or product defect, satisfaction with and difficulty in using the connection system. Technical problem and product defect shall be observed and evaluated by patient and data recorded by using a patient's diary. Satisfaction with and difficulty in using the connection systems will be evaluated by investigator in global fashion through a questionnaire.
Safety: Safety and tolerability assessments will consist of
- Monitoring and recording all adverse events and serious adverse events.
- Regular performance of physical examinations, including vital signs.
- Regular monitoring of haematology and blood chemistry parameters.
- Conditions
- Chronic Renal Failure
- Being tested
- Baxter's UltraBag® and FMC Andy·Disc®
- Keywords
- Continuous ambulatory peritoneal dialysis (CAPD), Peritonitis, ANDY-disc® (Fresenius Medical care), Ultra® (Baxter), Twin bag System
- Medical subject headings
- Kidney Failure, Chronic, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxter's UltraBag® and FMC Andy·Disc®Device
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the equivalence of ANDY-disc® with Ultrabag® for a treatment period of 12 months in patients on CAPD with respect to peritonitis rate.
Secondary outcomes (2)
To compare ANDY-disc® with Ultrabag® with respect to technique failure
To compare ANDY-disc® with Ultrabag® with respect to their respective frequency of technical problem or product defect, satisfaction with and difficulty in using the connection system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startMay 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Collaborators
- Fresenius Medical Care North America, Baxter Healthcare Corporation
- Investigators
- Zaki Morad, MRCP, FRCP, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255619
- Sponsor's protocol ID
- CT2372
- Status last verified
- Nov 2005
- First submitted
- 17 Nov 2005
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Open Label Trial to Establish the Equivalence Between ANDY-Disc® (Fresenius Medical Care) and Ultrabag® (Baxter) in Patients on CAPD. [CAPD-2 Trial]
- ClinicalTrials.gov ID
- NCT00255619
- Acronym / sponsor ID
- CT2372
- Conditions
- Chronic Renal Failure
- Keywords
- Continuous ambulatory peritoneal dialysis (CAPD), Peritonitis, ANDY-disc® (Fresenius Medical care), Ultra® (Baxter), Twin bag System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Collaborators
- Fresenius Medical Care North America, Baxter Healthcare Corporation
- Study start
- May 2002
- Study completion
- May 2004
- First posted
- 21 Nov 2005 (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.
Apart from haemodialysis, continuous ambulatory peritoneal dialysis (CAPD) is another effective therapy for end stage renal disease (ESRD). The Achilles heel of CAPD however is peritonitis, which is a major cause of morbidity and mortality in CAPD patients. Advances in connectology, such as the disconnect system, have resulted in reduced rate of peritonitis. The disconnect system which incorporated a Y-connection allow contamination occurring at the time of connection of the system to flush into the drainage bag thereby reducing the size of microorganism innoculum entering the peritoneal cavity. In recent years, the twin bag system where both the infusion and drainage bags are pre-attached to the Y tubing, has resulted in further reduction in peritonitis rate.
Two different twin bags systems are being introduced into the MOH hospitals. They are Baxter UltraBag® and Fresenius Andy·Disc®.
Even though both the systems are very similar, our own experience suggest that minor variation in the connectology could translate into marked differences in the peritonitis rate. In this multi centre, randomised controlled study, both the twin bag systems will be evaluated to establish their equivalence with respect to the incidence of peritonitis and technique failure.
Detailed description
This is a multi-centre, open label, parallel group randomized trial designed to demonstrate the therapeutic equivalence of ANDY-Disc® with Ultrabag® for a treatment period of 12 months. 270 patients on CAPD from 6 participating sites who met inclusion/exclusion criteria were enrolled into the trial. After initial screening, patients attended clinic for baseline examination, including clearance studies. Subjects were then randomly allocated to ANDY-Disc® or Ultrabag® in a ratio of 1:1. Study visits occurred every 2 weeks through 4 weeks, then every 4 weeks through 12 weeks, and every 12 weeks thereafter for the duration of the study (12 months). Hence there were a total of 7 visits (1 screen/baseline, 2 biweekly, 2-4 weekly and 2-6 monthly treatment visits, the last being the final visit).
Safety and tolerability assessments consisted of monitoring adverse events and serious adverse events, monitoring of haematology, blood chemistry and regular performance of physical examinations.
Criteria for evaluation:
Efficacy: Primary efficacy parameter:The primary efficacy variable will be the incidence of peritonitis. Peritonitis is defined as the presence of at least two of the following
- Abdominal pain or tenderness
- Presence of white blood cells in peritoneal effluent in excess of 100 cells per mL composed of at least 50% polymorphs
- Positive cultureSecondary efficacy parameter:
The secondary efficacy variables are:
- Technique failure; defined as transfer to haemodialysis or death. Note that cross-over to a comparator treatment will be considered as withdrawal.
Frequency of technical problem or product defect, satisfaction with and difficulty in using the connection system. Technical problem and product defect shall be observed and evaluated by patient and data recorded by using a patient's diary. Satisfaction with and difficulty in using the connection systems will be evaluated by investigator in global fashion through a questionnaire.
Safety: Safety and tolerability assessments will consist of
- Monitoring and recording all adverse events and serious adverse events.
- Regular performance of physical examinations, including vital signs.
- Regular monitoring of haematology and blood chemistry parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained from patient or parents/guardian.
- New or existing patients (on the single bag system) with end stage renal failure in the MOH CAPD programme with indications for using the twin bag system. For the purpose of this trial, these indications are:
Key exclusion criteria (7 listed)
- Participation in any CAPD trial in which the patient received an investigational product within 30 days preceding the screening phase of this study.
- Those persons directly involved in the conduct of the study.
- History of non-compliance to medical regimen or patients who are unwilling or unable to comply with the protocol.
- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
- Patients expected to be transferred to a non participating centre within the next six 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 |
|---|---|---|
| Baxter's UltraBag® and FMC Andy·Disc® | Device | – |
Primary outcome
To establish the equivalence of ANDY-disc® with Ultrabag® for a treatment period of 12 months in patients on CAPD with respect to peritonitis rate.
2 secondary outcomes
To compare ANDY-disc® with Ultrabag® with respect to technique failure
To compare ANDY-disc® with Ultrabag® with respect to their respective frequency of technical problem or product defect, satisfaction with and difficulty in using the connection system.
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 26 Oct 2006.
- the link is an academic research organisation for the trialLink provided by the sponsor.
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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.
Zaki Morad, MRCP, FRCP principal investigator
Ministry of Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baxter's UltraBag® and FMC Andy·Disc® in people with Chronic Renal Failure, run by Ministry of Health, Malaysia at 6 sites 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 7 inclusion and 7 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 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
To establish the equivalence of ANDY-disc® with Ultrabag® for a treatment period of 12 months in patients on CAPD with respect to peritonitis rate.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2006.