Open Label Trial to Establish the Equivalence Between ANDY-Disc® and Ultrabag® in Patients on CAPD.

NCT00255619 | Completed Phase 4

• 1 other identifier: CT2372
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Chronic Renal Failure

Keywords

Continuous ambulatory peritoneal dialysis (CAPD); Peritonitis; ANDY-disc® (Fresenius Medical care); Ultra® (Baxter); Twin bag System

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Baxter's UltraBag® and FMC Andy·Disc® DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead
• Fresenius Medical Care North America: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (6)

Department of Medicine, Sultanah Aminah Hospital

Johor Bharu, Johor, Malaysia

Location

Department of Nephrology, Kuala Lumpur Hospital

Kuala Lumpur, Kuala Lumpur, Malaysia

Location

Department of Pediatrics, Kuala Lumpur Hospital

Kuala Lumpur, Kuala Lumpur, Malaysia

Location

Department of Medicine, Seremban Hospital

Seremban, Negeri Sembilan, Malaysia

Location

Department of Medicine, Penang Hospital

George Town, Pulau Pinang, Malaysia

Location

Department of Nephrology,Selayang Hospital

Selayang Baru Utara, Selangor, Malaysia

Location

Related Links

• the link is an academic research organisation for the trial

MeSH Terms

Conditions

Kidney Failure, Chronic; Peritonitis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Zaki Morad, MRCP, FRCP

  Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: May 1, 2002
• Study Completion: May 1, 2004
• Last Updated: October 26, 2006

Record last verified: 2005-11

Locations

MY (6)