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
Plain Language Summary
Simplified for easier understanding
This study compares two types of dialysis fluid used in peritoneal dialysis (a kidney treatment done at home through your abdomen) for people with end-stage kidney disease. One fluid is the standard type currently used, and the other is a newer solution that is gentler and may better preserve whatever kidney function you have left. Keeping some remaining kidney function for as long as possible can greatly improve your quality of life.
You may be eligible if:
- You have been diagnosed with end-stage kidney disease
- You are starting dialysis treatment for the first time (within the past 90 days)
- You have been chosen to use peritoneal dialysis (CAPD or APD)
- Your kidneys still filter at least 5 ml/min/1.73m2
- Your urine output is at least 400 ml per day
- You are 18 years of age or older
- You are able to understand the study and give written consent
You may NOT be eligible if:
- Your expected survival is less than 12 months
- You are pregnant or breastfeeding
- You have had a cancer (other than certain treated skin or cervical cancers) in the last 5 years
- You have an active infection
- You have abdominal wall problems (injury, hernia, burns, skin conditions) that would prevent peritoneal dialysis
- You have inflammatory bowel disease, abdominal tumours, or bowel obstruction
- You have a condition (mental or physical) that prevents you from following the study protocol
- You are allergic to the study product
- You are in another trial affecting kidney function
Talk to your doctor about whether this trial might be right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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