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Trial registered on ANZCTR


Registration number
ACTRN12606000044527
Ethics application status
Approved
Date submitted
25/01/2006
Date registered
27/01/2006
Date last updated
16/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring peritoneal dialysis (PD) due to end-stage renal disease 1006 0
Condition category
Condition code
Renal and Urogenital 1082 1082 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational drug - balance solutions in Biofine, platicizer-free solution bags
Intervention code [1] 864 0
None
Comparator / control treatment
Control Drug - stay-safe conventional, standard PD solutions in Biofine, platicizer-free solution bags.
Each patient will complete a minimum of 12 months treatment of either PD solution with a maximum treatment period of 24 months.
Control group
Active

Outcomes
Primary outcome [1] 1447 0
The evolution of residual renal function measured as GFR (mean of renal urea and creatinine clearance) over time (treatment period 24 months).
Timepoint [1] 1447 0
Secondary outcome [1] 2576 0
Time from initiation of PD to anuria
Timepoint [1] 2576 0
Secondary outcome [2] 2577 0
Dialysis adequacy indices (not at Month 1)
Timepoint [2] 2577 0
Secondary outcome [3] 2578 0
Peritoneal transporter status (PET)
Timepoint [3] 2578 0
At 1, 6, 12, 18 and 24 months
Secondary outcome [4] 2579 0
Technique survival
Timepoint [4] 2579 0
Secondary outcome [5] 2580 0
Patient survival
Timepoint [5] 2580 0
Secondary outcome [6] 2581 0
All peritonitis episodes will be recorded
Timepoint [6] 2581 0
Secondary outcome [7] 2582 0
Safety
Timepoint [7] 2582 0
Secondary outcome [8] 2583 0
Adverse events
Timepoint [8] 2583 0
At Month 3, 6, 9, 12, 18 and 24.
Secondary outcome [9] 2584 0
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).
Timepoint [9] 2584 0
At Month 0, 6, 12, 18 and 24.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prognosis for survival less than 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 into the study- 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- 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- Any intra-abdominal tumours or intestinal obstruction- Any patient with 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 trial product or related products- Participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by secure web-based system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated randomisation schedule
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1185 0
Commercial sector/Industry
Name [1] 1185 0
Fresenius Medical Care Asia Pacific
Address [1] 1185 0
Country [1] 1185 0
Hong Kong
Funding source category [2] 1186 0
Commercial sector/Industry
Name [2] 1186 0
Fresenius Medical Care Australia Pty Ltd
Address [2] 1186 0
Country [2] 1186 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fresenius Medical Care Asia Pacific & Fresenius Medical Care Pty Ltd.
Address
Country
Hong Kong
Secondary sponsor category [1] 1044 0
None
Name [1] 1044 0
None
Address [1] 1044 0
Country [1] 1044 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36166 0
Address 36166 0
Country 36166 0
Phone 36166 0
Fax 36166 0
Email 36166 0
Contact person for public queries
Name 10053 0
Prof David Johnson
Address 10053 0
Renal Unit
Princess Alexandra Hospital
Cornwall Street
Wolloongabba QLD 4102
Country 10053 0
Australia
Phone 10053 0
+61 7 32405080
Fax 10053 0
Email 10053 0
David_Johnson@health.qld.gov.au
Contact person for scientific queries
Name 981 0
Dr Fiona Brown
Address 981 0
Renal Unit
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 981 0
Australia
Phone 981 0
+61 3 95943525
Fax 981 0
Email 981 0
fiona.brown@med.monash.ed.au

No information has been provided regarding IPD availability
Summary results
No Results