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| autoid | 99 |
| crg_id | CRG010600035 |
| titleoftrial | 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 |
| acronymnoftrial | balANZ Study |
| website | http:// |
| identificationno | ACTRN12606000044527 |
| leadprefix | Prof |
| leadsurname | Johnson |
| leadgivennames | David |
| leadposition | Director of Nephrology |
| leaddepartment | Renal Medicine |
| leadorganisation | Princess Alexandra Hospital |
| leadaddress | Cornwall Street, Wolloongabba, QLD 4102 Australia |
| leademail | David_Johnson@health.qld.gov.au |
| leadphone | +61 7 3240 5080 |
| leadfax | +61 7 3240 7485 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Fiona |
| contactgivennames | Brown |
| contactposition | Nephrologist & Co-Lead Investigator for the balANZ Study |
| contactdepartment | Dept of Nephrology |
| contactorganisation | Monash Medical Centre - Renal Unit |
| contactaddress | 246 Clayton Rd Clayton VIC 3168 Australia |
| contactemail | fiona.brown@med.monash.edu.au |
| contactphone | +61 3 9564 3525 |
| contactfax | |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | Fresenius Medical Care Asia Pacific & Fresenius Medical Care Australia Pty Ltd. |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 08/2004 |
| actualstart | 08/2004 |
| proposedcompletiondate | 09/2007 |
| actualcompletiondate | 09/2007 |
| multi_center_study | yes |
| numberofcentres | 14 |
| multi_national_study | yes |
| countrycentres | Australia, New Zealand, Singapore |
| researchquestion | To investigate the influence of balance solution on the evolution of residual renal function in comparison to change in residual renal function when treatment is with a standard PD solution. |
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | End-stage renal disease |
| intervention1 | balance solutions in Biofine, platicizer-free solution bags |
| intervention2 | stay-safe conventional, standard PD solutions in Biofine, platicizer-free solution bags |
| intervention3 | N/A |
| intervention4 | N/A |
| participants_gender | both |
| participants_other | adults |
| age | greater than or equal to 18 years of age to less than 81 years of age |
| totalrecruitment | 420 |
| inclusion | 1.Male or female patients, age greater than or equal to 18 years and < 81 years
2.Diagnosis of end stage renal disease 3.First treatment for ESRD 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/APD and they consent in advance to enter the study) 4.Selected to be treated by CAPD/APD 5.Residual GFR at enrolment >/= 5 ml/min/1.73m2 6.Urine volume per day >/=400 ml at enrolment 7.Written informed consent before any trial related activities 8.Ability to understand the nature & requirements of this trial |
| exclusion | 1.Prognosis for survival less than 12 months
2.Pregnancy or lactation period 3.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 4.Any acute infections at the time of enrolment into the study 5.Any disease of the abdominal wall such as injury or surgery, burns, hernia, dermatitis in the opinion of the Investigator would preclude the patient from being able to have peritoneal dialysis 6.Any Inflammatory bowel diseases (Crohns' disease, ulcerative colitis or diverticulitis) in the opinion of the Investigator would preclude the patient from being able to have peritoneal dialysis 7.Any intra-abdominal tumours or intestinal obstruction 8.Any patient with active serositis 9.Any condition (mental or physical) that would interfere with the patient's ability to comply with the study protocol 10.Known or suspected allergy to trial product or related products 11.Participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function |
| primaryoutcomes | Regression of renal GFR on time |
| secondaryoutcomes | Measures of dialysis adequacy, ultrafiltration capacity, renal function survival, technique survival, patient survival, peritonitis rate and clinical status parameters. |
| reference | 1. Brown F. Johnson DW. A randomized controlled trial to determine whether treatment with at neutral pH, low glucose degradation product dialysate (balance) prolongs residual renal function in peritoneal dialysis patients.[comment]. Peritoneal Dialysis International. 26(1):112-3; author reply 114, 2006 Jan-Feb. [added by Gail Higgins 20/08/2007] ACTRN12606000044527 |