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.

Category Primary study
Registry of TrialsANZCTR
Year 2006
INTERVENTION: Investigational drug ‐ balance solutions in Biofine, platicizer‐free solution bags CONDITION: Patients requiring peritoneal dialysis (PD) due to end‐stage renal disease PRIMARY OUTCOME: The evolution of residual renal function measured as GFR (mean of renal urea and creatinine clearance) over time (treatment period 24 months). SECONDARY OUTCOME: Adverse events All peritonitis episodes will be recorded Dialysis adequacy indices (not at Month 1) Monitoring of systemic, urinary and peritoneal markers of renal fibrosis and inflammation (The collection and analysis of these markers will not include any DNA testing). Patient survival Peritoneal transporter status (PET) Safety Technique survival Time from initiation of PD to anuria INCLUSION CRITERIA: 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.
Epistemonikos ID: 1f98d14552b827a5b4edd8947404471d0622b177
First added on: Aug 21, 2024