Status:
COMPLETED
Open Label Trial to Establish the Equivalence Between ANDY-Disc® and Ultrabag® in Patients on CAPD.
Lead Sponsor:
Ministry of Health, Malaysia
Collaborating Sponsors:
Fresenius Medical Care North America
Baxter Healthcare Corporation
Conditions:
Chronic Renal Failure
Eligibility:
All Genders
Phase:
PHASE4
Brief 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...
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00255619
Start Date
May 1 2002
End Date
May 1 2004
Last Update
October 26 2006
Active Locations (6)
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1
Department of Medicine, Sultanah Aminah Hospital
Johor Bharu, Johor, Malaysia
2
Department of Nephrology, Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia
3
Department of Pediatrics, Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia
4
Department of Medicine, Seremban Hospital
Seremban, Negeri Sembilan, Malaysia