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Sponsors and Collaborators: |
Ministry of Health, Malaysia Fresenius Medical Care North America Baxter Healthcare Corporation |
Information provided by: | Ministry of Health, Malaysia |
ClinicalTrials.gov Identifier: | NCT00255619 |
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.
Condition | Intervention | Phase |
Chronic Renal Failure |
Device: Baxter’s UltraBag® and FMC Andy·Disc® |
Phase IV |
MedlinePlus related topics: | Kidney Failure |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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] |
Estimated Enrollment: | 264 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | May 2004 |
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
The secondary efficacy variables are:
1. 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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Malaysia | |||||
Department of Medicine, Penang Hospital | |||||
Penang, Malaysia | |||||
Malaysia, Federal Territory | |||||
Department of Nephrology, Kuala Lumpur Hospital | |||||
Kuala Lumpur, Federal Territory, Malaysia | |||||
Department of Pediatrics, Kuala Lumpur Hospital | |||||
Kuala Lumpur, Federal Territory, Malaysia | |||||
Malaysia, Johor | |||||
Department of Medicine, Sultanah Aminah Hospital | |||||
Johor Bharu, Johor, Malaysia | |||||
Malaysia, Negeri Sembilan | |||||
Department of Medicine, Seremban Hospital | |||||
Seremban, Negeri Sembilan, Malaysia | |||||
Malaysia, Selangor | |||||
Department of Nephrology,Selayang Hospital | |||||
Selayang, Selangor, Malaysia |
Ministry of Health, Malaysia |
Fresenius Medical Care North America |
Baxter Healthcare Corporation |
Principal Investigator: | Zaki Morad, MRCP, FRCP | Netherlands: Ministry of Health, Welfare and Sports |
the link is an academic research organisation for the trial 
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Study ID Numbers: | CT2372 |
First Received: | November 17, 2005 |
Last Updated: | October 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00255619 |
Health Authority: | Malaysia: Ministry of Health |
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