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

This study has been completed.
Sponsor:
Collaborators:
Fresenius Medical Care North America
Baxter Healthcare Corporation
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT00255619
First received: November 17, 2005
Last updated: October 25, 2006
Last verified: November 2005
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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]

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 264
Study Start Date: May 2002
Estimated Study Completion Date: May 2004
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

  1. Abdominal pain or tenderness
  2. Presence of white blood cells in peritoneal effluent in excess of 100 cells per mL composed of at least 50% polymorphs
  3. Positive cultureSecondary efficacy parameter:

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

  1. Monitoring and recording all adverse events and serious adverse events.
  2. Regular performance of physical examinations, including vital signs.
  3. Regular monitoring of haematology and blood chemistry parameters.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained from patient or parents/guardian.
  2. 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 Criteria:

  1. Participation in any CAPD trial in which the patient received an investigational product within 30 days preceding the screening phase of this study.
  2. Those persons directly involved in the conduct of the study.
  3. History of non-compliance to medical regimen or patients who are unwilling or unable to comply with the protocol.
  4. 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.
  5. Patients expected to be transferred to a non participating centre within the next six months
  6. Patients presently on a twin bag system
  7. Use of automated cycler assistance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255619

Locations
Malaysia
Department of Nephrology, Kuala Lumpur Hospital
Kuala Lumpur, Federal Territory, Malaysia
Department of Pediatrics, Kuala Lumpur Hospital
Kuala Lumpur, Federal Territory, Malaysia
Department of Medicine, Sultanah Aminah Hospital
Johor Bharu, Johor, Malaysia
Department of Medicine, Seremban Hospital
Seremban, Negeri Sembilan, Malaysia
Department of Nephrology,Selayang Hospital
Selayang, Selangor, Malaysia
Department of Medicine, Penang Hospital
Penang, Malaysia
Sponsors and Collaborators
Ministry of Health, Malaysia
Fresenius Medical Care North America
Baxter Healthcare Corporation
Investigators
Principal Investigator: Zaki Morad, MRCP, FRCP Netherlands: Ministry of Health, Welfare and Sports
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00255619     History of Changes
Other Study ID Numbers: CT2372
Study First Received: November 17, 2005
Last Updated: October 25, 2006
Health Authority: Malaysia: Ministry of Health

Keywords provided by Ministry of Health, Malaysia:
Continuous ambulatory peritoneal dialysis (CAPD)
Peritonitis
ANDY-disc® (Fresenius Medical care)
Ultra® (Baxter)
Twin bag System

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 18, 2014