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Trial registered on ANZCTR


Registration number
ACTRN12613000749707
Ethics application status
Approved
Date submitted
26/06/2013
Date registered
4/07/2013
Date last updated
12/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors controlling calciprotein particle (CPP) formation in peritoneal dialysis (PD) fluid
Scientific title
Assessing the peritoneal dialysis effluent for the presence of calciprotein particles in patients undergoing peritoneal dialysis
Secondary ID [1] 282748 0
Nil
Universal Trial Number (UTN)
Trial acronym
PDF Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 289481 0
Condition category
Condition code
Renal and Urogenital 289802 289802 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessing the peritoneal dialysis effluent for the presence of calciprotein particles. Once a week for 8 weeks, in no particular order, participants will administer a specified PD fluid bag (listed below) and return that bag of effluent for analysis. The PD bags are:
1. Dianeal 1.5% PD4
2. Dianeal 4.25% PD4
3. Physioneal 1.36% PD4
4. Physioneal 3.86 % PD4
5. Extraneal 7.5%
6. Nutrineal 1.1%
7. Dianeal 1.5% PD2
8. Dianeal 1.5% PD1
Intervention code [1] 287410 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289876 0
CPP levels will be estimated by assessing the apparent reduction in total fetuin-A concentration (measured by specific ELISA) after high-speed centrifugation as previously described in Smith ER et al 2013 Nephrology 18(3):215-21.
Timepoint [1] 289876 0
Once a week after each exchange for 8 weeks
Secondary outcome [1] 303461 0
Fluid pH will be measured by potentiometry using a pH electrode.
Timepoint [1] 303461 0
Once a week after each exchange for 8 weeks

Eligibility
Key inclusion criteria
Peritoneal dialysis patients
A peritoneal equilibration test (PET) within the last 6 months
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comply with the protocol
Allergy or problem with one of the PD fluid solutions proposed
Peritonitis within the last 6 weeks

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis based upon preliminary data where the mean CPP% in PD fluid is 21 with standard deviation of 5. A sample size of 14 patients should detect a significant 5% difference (p<0.05) in mean CPP level with a 80% power.

Recruitment
Recruitment status
Completed
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)
VIC

Funding & Sponsors
Funding source category [1] 287516 0
Commercial sector/Industry
Name [1] 287516 0
Baxter Healthcare Corporation
Address [1] 287516 0
One Baxter Parkway
Deerfield, IL 60015
Country [1] 287516 0
United States of America
Primary sponsor type
Hospital
Name
Eastern Health Integrated Renal Service
Address
Level 2, 5 Arnold Street
Box Hill, Victoria, 3128
Country
Australia
Secondary sponsor category [1] 286262 0
Hospital
Name [1] 286262 0
The Royal Melbourne Hospital Kidney Care Services
Address [1] 286262 0
Grattan St Parkville VIC 3050
Country [1] 286262 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289494 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 289494 0
5 Arnold Street
Box Hill, Victoria, 3128
Ethics committee country [1] 289494 0
Australia
Date submitted for ethics approval [1] 289494 0
12/03/2013
Approval date [1] 289494 0
21/03/2013
Ethics approval number [1] 289494 0
LR73/1213

Summary
Brief summary
There is a need to better understand the mechanisms involved in peritoneal membrane deterioration in patients undergoing peritoneal dialysis. We have found that a recently discovered particle (calciprotein particle, CPP) is present at high levels in drained out peritoneal dialysis fluid (PDF). Experimental work suggests that CPP may promote inflammation and calcification in certain situations. This is a pilot study to ascertain whether differences in PDF composition, in particular with respect to fluid glucose and calcium concentration, effect the formation and levels of CPP present in drained PDF. We hypothesise that PDF containing higher glucose and calcium concentrations would be associated with greater intra-peritoneal CPP accumulation, which may predispose to peritoneal inflammation, calcification and ultimately, technique failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41078 0
Prof Lawrence McMahon
Address 41078 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street
Box Hill, Victoria, 3128
Country 41078 0
Australia
Phone 41078 0
+61 3 9091 8872
Fax 41078 0
Email 41078 0
lawrence.mcmahon@easternhealth.org.au
Contact person for public queries
Name 41079 0
Prof Steve Holt
Address 41079 0
The Royal Melbourne Hospital Kidney Care Services Hospital Grattan St
Parkville, Victoria, 3050
Country 41079 0
Australia
Phone 41079 0
+61 3 9342 7058
Fax 41079 0
Email 41079 0
steve.holt@mh.org.au
Contact person for scientific queries
Name 41080 0
Mr Ed Smith
Address 41080 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street
Box Hill, Victoria, 3128
Country 41080 0
Australia
Phone 41080 0
+61 3 9091 8872
Fax 41080 0
Email 41080 0
ed.smith@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary