A Randomized, Multi-center, Open label trial to establish the equivalence between Staysafe®/ANDY-Disc® (Fresenius Medical Care) and Ultrabag® (Baxter) in patients on CAPD. [CAPD-2 Trial]
CAPD2 Trial
General Information
264 patients on CAPD from 6 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial.
After initial screening, patients will attend clinic for baseline examination, including clearance studies. Subjects will then be randomly allocated to Staysafe/ANDY-disc® or Ultrabag® in a ratio of 1:1.
Study visits will occur every 2 week 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 will be 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).
Study Information
Inclusion & Exclusion 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 single bag system who for various reasons could no longer continue with the system.
Existing CAPD patients 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
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 single bag system who for various reasons could no longer continue with the system.
Existing CAPD patients 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
Study Timeline