Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function

Abstract

BackgroundThe main hypothesis of this study is that neutral pH, low glucose degradation product (GDP) peritoneal dialysis (PD) fluid better preserves residual renal function in PD patients over time compared with conventional dialysate.Methods/DesignInclusion criteria are adult PD patients (CAPD or APD) aged 18-81 years whose first dialysis was within 90 days prior to or following enrolment and who have a residual GFR ≥ 5 ml/min/1.73 m2, a urine output ≥ 400 ml/day and an ability to understand the nature and requirements of this trial. Pregnant or lactating patients or individuals with an active infection at the time of enrolment, a contra-indication to PD or participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function are excluded. Patients will be randomized 1:1 to receive either neutral pH, low GDP dialysis solution (Balance®) or conventional dialysis solution (Stay.safe®) for a period of 2 years. During this 2 year study period, urinary urea and clearance measurements will be performed at 0, 3, 6, 9, 12, 18 and 24 months. The primary outcome measure will be the slope of residual renal function decline, adjusted for centre and presence of diabetic nephropathy. Secondary outcome measures will include time from initiation of peritoneal dialysis to anuria, peritoneal small solute clearance, peritoneal transport status, peritoneal ultrafiltration, technique survival, patient survival, peritonitis rates and adverse events. A total of 185 patients has been recruited into the trial.DiscussionThis investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysis solution for preserving residual renal function in PD patients.Trial RegistrationAustralian New Zealand Clinical Trials Registry Number: ACTRN12606000044527

Effects of Biocompatible versus Standard Fluid on Peritoneal Dialysis Outcomes

“…For example, the absence of beneficial effect in the randomized trial by Fan et al 15 could be explained by the fact that 91% of patients in the intervention group received Physioneal, which is reported to contain levels of 3-dexoyglucosone (70-161 mmol/L depending on dialysate glucose concentration 27 ) that are intermediate between those of the intervention group (42-60 mmol/L) and the control group (173-324 mmol/L) in this study. 28 An alternative explanation for a possible renoprotective benefit of biocompatible fluid is reduced peritonitis risk. Numerous studies previously demonstrated that peritonitis and/or its subsequent treatment with nephrotoxic antibiotics are major risk factors for residual renal function decline.…”

“…28 This study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000044527) and the study protocol was approved by ethics committees at all participating centers. All patients provided written informed consent before trial participation.…”

Longitudinal Trend in Lipid Profile of Incident Peritoneal Dialysis Patients is Not Influenced by the Use of Biocompatible Solutions

“…A detailed description of the study design and methodology has been previously published (17), as have the results of the main primary and secondary analyses (16,(18)(19)(20)(21) The primary clinical outcome measure was number of episodes of a composite CVE as defined previously (20). A secondary clinical outcome measure was all-cause mortality during the study duration.…”

Utility of Urinary Biomarkers in Predicting Loss of Residual Renal Function: The BAL Anz Trial

“…A detailed description of the study design and methodology has previously been published (23), as have the results of the main primary and secondary analyses (22,24,25). The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000044527).…”