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

Overview

Journal BMC Nephrol

Publisher Biomed Central

Specialty Nephrology

Date 2010 Sep 17

PMID 20843375

Citations 13

Authors

David W Johnson

Margaret Clarke

Vanessa Wilson

Feidhlim Woods

Fiona G Brown

Affiliations

Soon will be listed here.

Abstract

Background: The 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/design: Inclusion 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.

Discussion: This 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 Registration: Australian New Zealand Clinical Trials Registry Number: ACTRN12606000044527.

Citing Articles

Biocompatible dialysis fluids for peritoneal dialysis.

Htay H, Johnson D, Wiggins K, Badve S, Craig J, Strippoli G Cochrane Database Syst Rev. 2018; 10:CD007554.

PMID: 30362116 PMC: 6517187. DOI: 10.1002/14651858.CD007554.pub3.

microRNA regulation of peritoneal cavity homeostasis in peritoneal dialysis.

Lopez-Anton M, Bowen T, Jenkins R Biomed Res Int. 2015; 2015:929806.

PMID: 26495316 PMC: 4606405. DOI: 10.1155/2015/929806.

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

Cho Y, Buchel J, Steppan S, Passlick-Deetjen J, Hawley C, Dimeski G Perit Dial Int. 2015; 36(2):146-53.

PMID: 26429421 PMC: 4803359. DOI: 10.3747/pdi.2014.00291.

Higher Dialysate Matrix Metalloproteinase-2 Levels Are Associated with Peritoneal Membrane Dysfunction.

Cho Y, Johnson D, Vesey D, Hawley C, Pascoe E, Clarke M Perit Dial Int. 2014; 36(1):16-25.

PMID: 25292407 PMC: 4737561. DOI: 10.3747/pdi.2013.00274.

Effect of biocompatible peritoneal dialysis solution on residual renal function: a systematic review of randomized controlled trials.

Seo E, An S, Cho J, Suh H, Park S, Gwak H Perit Dial Int. 2014; 34(7):724-31.

PMID: 25185015 PMC: 4269498. DOI: 10.3747/pdi.2012.00331.

References

Lee H, Park H, Seo B, Do J, Yun S, Song H . Superior patient survival for continuous ambulatory peritoneal dialysis patients treated with a peritoneal dialysis fluid with neutral pH and low glucose degradation product concentration (Balance). Perit Dial Int. 2005; 25(3):248-55. View

Topley N . In vitro biocompatibility of bicarbonate-based peritoneal dialysis solutions. Perit Dial Int. 1997; 17(1):42-7. View

Krediet R . 30 years of peritoneal dialysis development: the past and the future. Perit Dial Int. 2007; 27 Suppl 2:S35-41. View

Szeto C, Chow K, Lam C, Leung C, Kwan B, Chung K . Clinical biocompatibility of a neutral peritoneal dialysis solution with minimal glucose-degradation products--a 1-year randomized control trial. Nephrol Dial Transplant. 2006; 22(2):552-9. DOI: 10.1093/ndt/gfl559. View

Vonesh E, Snyder J, Foley R, Collins A . Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us?. Kidney Int Suppl. 2006; (103):S3-11. DOI: 10.1038/sj.ki.5001910. View

Cho Y, Johnson D, Craig J, Strippoli G, Badve S, Wiggins K . Biocompatible dialysis fluids for peritoneal dialysis. Cochrane Database Syst Rev. 2014; (3):CD007554. DOI: 10.1002/14651858.CD007554.pub2. View

Rumpsfeld M, McDonald S, Johnson D . Peritoneal small solute clearance is nonlinearly related to patient survival in the Australian and New Zealand peritoneal dialysis patient populations. Perit Dial Int. 2009; 29(6):637-46. View

van Olden R, Krediet R, Struijk D, Arisz L . Measurement of residual renal function in patients treated with continuous ambulatory peritoneal dialysis. J Am Soc Nephrol. 1996; 7(5):745-50. DOI: 10.1681/ASN.V75745. View

Williams J, Topley N, Craig K, Mackenzie R, Pischetsrieder M, Lage C . The Euro-Balance Trial: the effect of a new biocompatible peritoneal dialysis fluid (balance) on the peritoneal membrane. Kidney Int. 2004; 66(1):408-18. DOI: 10.1111/j.1523-1755.2004.00747.x. View

10.

Mortier S, Faict D, Schalkwijk C, Lameire N, De Vriese A . Long-term exposure to new peritoneal dialysis solutions: Effects on the peritoneal membrane. Kidney Int. 2004; 66(3):1257-65. DOI: 10.1111/j.1523-1755.2004.00879.x. View

11.

Topley N . Membrane longevity in peritoneal dialysis: impact of infection and bio-incompatible solutions. Adv Ren Replace Ther. 1998; 5(3):179-84. DOI: 10.1016/s1073-4449(98)70030-5. View

12.

Honda K, Nitta K, Horita S, Yumura W, Nihei H, Nagai R . Accumulation of advanced glycation end products in the peritoneal vasculature of continuous ambulatory peritoneal dialysis patients with low ultra-filtration. Nephrol Dial Transplant. 1999; 14(6):1541-9. DOI: 10.1093/ndt/14.6.1541. View

13.

SERKES K, Blagg C, Nolph K, Vonesh E, Shapiro F . Comparison of patient and technique survival in continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis: a multicenter study. Perit Dial Int. 1990; 10(1):15-9. View

14.

Termorshuizen F, Korevaar J, Dekker F, van Manen J, Boeschoten E, Krediet R . The relative importance of residual renal function compared with peritoneal clearance for patient survival and quality of life: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD )-2. Am J Kidney Dis. 2003; 41(6):1293-302. DOI: 10.1016/s0272-6386(03)00362-7. View

15.

Popovich R, Moncrief J, Nolph K, Ghods A, Twardowski Z, Pyle W . Continuous ambulatory peritoneal dialysis. Ann Intern Med. 1978; 88(4):449-56. DOI: 10.7326/0003-4819-88-4-449. View

16.

Bargman J, Thorpe K, Churchill D . Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study. J Am Soc Nephrol. 2001; 12(10):2158-2162. DOI: 10.1681/ASN.V12102158. View

17.

Fenton S, Schaubel D, Desmeules M, Morrison H, Mao Y, Copleston P . Hemodialysis versus peritoneal dialysis: a comparison of adjusted mortality rates. Am J Kidney Dis. 1997; 30(3):334-42. DOI: 10.1016/s0272-6386(97)90276-6. View

18.

Fan S, Pile T, Punzalan S, Raftery M, Yaqoob M . Randomized controlled study of biocompatible peritoneal dialysis solutions: effect on residual renal function. Kidney Int. 2007; 73(2):200-6. DOI: 10.1038/sj.ki.5002574. View

19.

Lee H, Choi H, Park H, Seo B, Do J, Yun S . Changing prescribing practice in CAPD patients in Korea: increased utilization of low GDP solutions improves patient outcome. Nephrol Dial Transplant. 2006; 21(10):2893-9. DOI: 10.1093/ndt/gfl393. View

20.

Witowski J, Jorres A . Effects of peritoneal dialysis solutions on the peritoneal membrane: clinical consequences. Perit Dial Int. 2005; 25 Suppl 3:S31-4. View