RecruitingPhase 4ACTRN12606000044527
balANZ Study: A multicentre, randomised, controlled trial to determine whether peritoneal dialysis treatment with a low GDP, neutral pH peritoneal dialysis (PD) solution (balance) compared to standard PD solution is associated with superior preservation of residual renal function.
Sponsor
Fresenius Medical Care Asia Pacific & Fresenius Medical Care Pty Ltd.
Enrollment
420 participants
Start Date
Aug 15, 2004
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- Diagnosis of end stage renal disease - First treatment for ESRD by any dialysis modality within 90 days prior to or following enrolment - Selected to be treated by CAPD/APD- Residual GFR at enrolment >/= 5 ml/min/1.73m2 - Urine volume per day >/= 400 ml at enrolment- Written informed consent before any trial related activities- Ability to understand the nature and requirements of this trial.
Exclusion Criteria1
- Prognosis for survival less than 12 months- Pregnancy or lactation period- History of malignancy other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix within the last 5 years- Any acute infections at the time of enrolment into the study- Any disease of the abdominal wall such as injury or surgery, burns, hernia, dermatitis in the opinion of the Investigator would preclude the patient from being able to have peritoneal dialysis- Any Inflammatory bowel diseases (Crohns’ disease, ulcerative colitis or diverticulitis) in the opinion of the Investigator would preclude the patient from being able to have peritoneal dialysis- Any intra-abdominal tumours or intestinal obstruction- Any patient with active serositis- Any condition (mental or physical) that would interfere with the patient’s ability to comply with the study protocol- Known or suspected allergy to trial product or related products- Participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function
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Interventions
Investigational drug - balance solutions in Biofine, platicizer-free solution bags
Investigational drug - balance solutions in Biofine, platicizer-free solution bags
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12606000044527