balANZ 2010.

Methods	Study design: open‐label, parallel RCT Study duration: November 2004 to September 2010 Follow‐up period: 24 months
Participants	Countries: Australia, New Zealand, Singapore Setting: multicentre (16 sites) Adult PD patients ≥ 18 and < 81 years (either CAPD or APD); diagnosis of ESKD; first treatment for ESKD by any dialysis modality within 90 days prior to or following enrolment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study); selected to be treated by CAPD or APD; residual GFR at enrolment ≥ 5 mL/min/1.73 m2, urine volume/d ≥ 400 mL at enrolment; written informed consent before any study related activities; ability to understand the nature and requirements of the study Number: treatment group (91); control group (91) Mean age ± SD (years): treatment group (59.3 ± 14.2); control group (57.9 ± 14.7) Sex (M/F): treatment group (52/39); control group (48/43) Exclusion criteria: prognosis for survival < 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; any disease of the abdominal wall, such as injury or surgery, burns, hernia, dermatitis, that in the opinion of the Investigator would preclude the patient from being able to have PD; any inflammatory bowel diseases (Crohn's disease, ulcerative colitis or diverticulitis) that in the opinion of the Investigator would preclude the patient from being able to have PD; any intra‐abdominal tumours or intestinal obstruction; 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 study product or related products; participation in any other clinical study where an intervention is designed to moderate rate of change of RRF
Interventions	Treatment group Neutral pH, low GDP dialysis solution (Balance) Control group Conventional dialysis solution (StaySafe) for a period of 2 years
Outcomes	Primary outcome Slope of RRF decline measured as GFR (mean of renal urea and CrCl) over time (follow‐up 24 months) Secondary outcomes Time from initiation of PD to anuria (daily urine volume < 100 mL) Peritoneal small solute clearance (Kt/V, CrCl) Peritoneal transport status (PET D/P creatinine and D/Do glucose) Peritoneal UF capacity (mL/d) and UF (mL/day/m2) Technical survival Patient survival Peritonitis rates Adverse events
Notes	Study funded by Fresenius Medical Care
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "To ensure adequate concealment of allocation, randomization was performed using a central computer and web‐based link to the central database, with stratification according to centre and the presence or absence of diabetic nephropathy"
Allocation concealment (selection bias)	Low risk	Quote: "To ensure adequate concealment of allocation, randomization was performed using a central computer and web‐based link to the central database, with stratification according to centre and the presence or absence of diabetic nephropathy"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "An open‐label study", but unlikely to have influenced the objective outcomes measured
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	Drop‐out rate 3/185 (1.6%), balanced between groups
Selective reporting (reporting bias)	Low risk	All relevant clinical parameters reported
Other bias	Unclear risk	Insufficient information to permit judgement