ANZCTR - Registration

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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

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

Condition category

Condition code

Renal and Urogenital

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]

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]

The evolution of residual renal function measured as GFR (mean of renal urea and creatinine clearance) over time (treatment period 24 months).

Timepoint [1]

Secondary outcome [1]

Time from initiation of PD to anuria

Timepoint [1]

Secondary outcome [2]

Dialysis adequacy indices (not at Month 1)

Timepoint [2]

Secondary outcome [3]

Peritoneal transporter status (PET)

Timepoint [3]

At 1, 6, 12, 18 and 24 months

Secondary outcome [4]

Technique survival

Timepoint [4]

Secondary outcome [5]

Patient survival

Timepoint [5]

Secondary outcome [6]

All peritonitis episodes will be recorded

Timepoint [6]

Secondary outcome [7]

Safety

Timepoint [7]

Secondary outcome [8]

Adverse events

Timepoint [8]

At Month 3, 6, 9, 12, 18 and 24.

Secondary outcome [9]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/08/2004

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

420

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fresenius Medical Care Asia Pacific

Address [1]

Country [1]

Hong Kong

Funding source category [2]

Commercial sector/Industry

Name [2]

Fresenius Medical Care Australia Pty Ltd

Address [2]

Country [2]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof David Johnson

Address

Renal Unit
Princess Alexandra Hospital
Cornwall Street
Wolloongabba QLD 4102

Country

Australia

Phone

+61 7 32405080

Fax

[email protected]

Contact person for scientific queries

Name

Dr Fiona Brown

Address

Renal Unit
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168

Country

Australia

Phone

+61 3 95943525

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Effects of Biocompatible versus Standard Fluid on Peritoneal Dialysis Outcomes	2012	https://doi.org/10.1681/asn.2011121201
Dimensions AI	The Effects of Biocompatible Compared with Standard Peritoneal Dialysis Solutions on Peritonitis Microbiology, Treatment, and Outcomes: The Balanz Trial	2012	https://doi.org/10.3747/pdi.2012.00052
Dimensions AI	Dialysate interleukin-6 predicts increasing peritoneal solute transport rate in incident peritoneal dialysis patients	2014	https://doi.org/10.1186/1471-2369-15-8
Embase	Utility of urinary biomarkers in predicting loss of residual renal function: The Balanz trial.	2015	https://dx.doi.org/10.3747/pdi.2013.00170
Embase	Longitudinal trend in lipid profile of incident peritoneal dialysis patients is not influenced by the use of biocompatible solutions.	2016	https://dx.doi.org/10.3747/pdi.2014.00291

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically