Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001250729
Ethics application status
Approved
Date submitted
5/11/2013
Date registered
13/11/2013
Date last updated
11/08/2021
Date data sharing statement initially provided
11/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Protein-bound uraemic toxins in Peritoneal Dialysis Patients
Scientific title
Removal of selected low molecular weight highly protein-bound uraemic toxins in patients on peritoneal dialysis
Secondary ID [1] 283522 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 290441 0
Condition category
Condition code
Renal and Urogenital 290829 290829 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
Measurement of protein binding of small molecular weight toxins in peritoneal dialysis effluent assessed on 2 occasions 1 month apart
Measurement is undertaken with an HPLC assay for simultaneous determination of 4 uraemic solutes:P Cresol,P Cresol Sulphate,Indoxyl Sulphate,3-indole-acteic acid based on methods described by Calaf et al:J Chromatogr B Analyt Technol Biomed Life Sci. 879(23):2281-2286.2011
Intervention code [1] 288224 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290824 0
The degree of protein binding for each of the measured solutes is established by measuring total solute in the PD effluent and then separating protein from the PD effluent and measuring the remaining free level. The difference is the bound solute which is expressed as a percentage of the total
Timepoint [1] 290824 0
At baseline and 1 month later
Secondary outcome [1] 305382 0
Bovine Serum albumin is added to the PD effluent at a range of concentrations likely to be achievable with wearable sorbent-based recycling PD. Total,bound and free solutes are measured.This enables the development of a binding curve related to protein concentrations
Timepoint [1] 305382 0
At baseline and 1 month later

Eligibility
Key inclusion criteria
Patients on Peritoneal Dialysis
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Peritonitis within 1 month
Excessive co-morbidity

Study design
Purpose
Screening
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The number to be studied, 30,although small, is large enough to cover the spectrum of protein excretion found in patients on PD. We do not expect a wide range of binding results

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/12/2013
Actual
Date of last participant enrolment
Anticipated
28/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5571 0
New Zealand
State/province [1] 5571 0

Funding & Sponsors
Funding source category [1] 288220 0
Hospital
Name [1] 288220 0
Auckland Hospital Renal Trust Fund
Country [1] 288220 0
New Zealand
Primary sponsor type
Individual
Name
John Collins
Address
Dept of Renal Medicine
Auckland City Hospital
Box 92024
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 286943 0
None
Name [1] 286943 0
Address [1] 286943 0
Country [1] 286943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290129 0
Northern A HDEC
Ethics committee address [1] 290129 0
Ethics committee country [1] 290129 0
New Zealand
Date submitted for ethics approval [1] 290129 0
13/11/2013
Approval date [1] 290129 0
30/11/2013
Ethics approval number [1] 290129 0
30/11/2013

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

Contacts
Principal investigator
Name 44106 0
A/Prof John Collins
Address 44106 0
Dept Renal Medicine
Auckland City Hospital
Park Road,Grafton
Auckland,1010
Country 44106 0
New Zealand
Phone 44106 0
64 9 3797440
Fax 44106 0
64 9 3074987
Email 44106 0
johnco@adhb.govt.nz
Contact person for public queries
Name 44107 0
John Collins
Address 44107 0
Dept Renal Medicine
Auckland City Hospital
Park Road,Grafton
Auckland 1010
Country 44107 0
New Zealand
Phone 44107 0
64 9 3797440
Fax 44107 0
64 9 3074987
Email 44107 0
johnco@adhb.govt.nz
Contact person for scientific queries
Name 44108 0
John Collins
Address 44108 0
Dept Renal Medicine
Auckland City Hospital
Park Road,Grafton
Auckland 1010
Country 44108 0
New Zealand
Phone 44108 0
64 9 3797440
Fax 44108 0
64 9 3074987
Email 44108 0
johnco@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.