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Trial registered on ANZCTR


Registration number
ACTRN12619000424101p
Ethics application status
Submitted, not yet approved
Date submitted
13/02/2019
Date registered
15/03/2019
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess biochemical efficacy of 2 dialysis membranes in the setting of nocturnal haemodialysis.
Scientific title
Pilot study to assess biochemical efficacy of 2 dialysis membranes in the setting of nocturnal haemodialysis.
Secondary ID [1] 297390 0
nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Dialysis dependent end-stage renal failure 311545 0
Condition category
Condition code
Renal and Urogenital 310183 310183 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extended hours (nocturnal) haemodialysis, using 2 different dialysis membranes.

Dialysis will be performed as per the patients' usual prescription (usually alternate day, 7-8 hours per session). No changes to the prescription will be made for the trial or during the trial; except for the membrane.

Patients will be randomly assigned to a sequence of the 2 membranes (details of membranes below). There will be no washout between the membranes but the test membrane will be in the mid-week session of the 4th week of each membrane. Each membrane will be tested for 4 weeks.

The regular dialysis sessions will occur at the patients' homes. Records of the home dialysis sessions will be reviewed to ensure membrane choice and dialysis parameters have been adhered to.

The test dialysis sessions (mid-week, 4th week of each membrane) will occur under nursing supervision at the home-dialysis training unit. During the test dialysis session, blood and dialysate collections will be taken to assess clearance of solutes and levels of biocompatibility markers.

The FX80 dialysis membrane (polysulfone), as the currently used standard, will be the comparator/control membrane.
The Nipro Solacia membrane (asymmetrical cellulose triacetate) will be the test membrane.
Intervention code [1] 313648 0
Treatment: Devices
Comparator / control treatment
Comparison of 2 dialysis membrane in the setting of extended hours (or nocturnal) haemodialysis.
The membranes to be tested are:
Fresenius FX-80 (polysulfone) - comparator/control membrane.
Nipro Solacia 190H (asymmetric cellulose triacetate) - details above.
Control group
Active

Outcomes
Primary outcome [1] 319067 0
Efficacy of dialysis - as measured by removal of uremic toxins (eg. urea, creatinine, phosphate, indoxyl sulfate, beta-2 microglobulin, alpha-1 microglobulin).
This will be assessed as "reduction ratios" - utilising blood samples from before the session and immediately after the session, with the reduction ratio calculated as Pre-Post/Pre x 100 (as a unitless number).
In addition "instantaneous clearances" will be calculated 1 hour into dialysis with blood samples from pre and post the dialysis membrane (also called arterial and venous samples), with the calculation Art-Ven/Art x 100.
Finally, the actual amount of each toxin removed, as appearing in the spent dialysate, will be calculated using partial dialysate collections.
Timepoint [1] 319067 0
The primary outcome (clearance) will be assessed at a single time point - being the mid-week session of the 4th week.
Secondary outcome [1] 366902 0
Safety of each membrane, as determined by haematological markers (FBE, clotting)
Timepoint [1] 366902 0
4 weeks, for each membrane

Eligibility
Key inclusion criteria
Existing nocturnal haemodialysis patients.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with dialysis difficulties, such as poor Arterio-venous access.
Those unwilling to consent.

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)
Nil - open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is a pilot study, with simple biochemical/laboratory endpoints. Comparison of results by paired t-test/ANOVA.

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment postcode(s) [1] 25637 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 301960 0
Commercial sector/Industry
Name [1] 301960 0
Nipro Corporation, Japan
Address [1] 301960 0
3-9-3 HONJO-NISHI KITA-KU OSAKA 531-8510 JAPAN
Country [1] 301960 0
Japan
Primary sponsor type
Hospital
Name
Monash Health, Clayton, Vic,
Address
246 Clayton Rd, Clayton, Vic, 3168.
Country
Australia
Secondary sponsor category [1] 301720 0
None
Name [1] 301720 0
Address [1] 301720 0
Country [1] 301720 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302640 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 302640 0
246 Clayton Rd, Clayton, Vic, 3168.
Ethics committee country [1] 302640 0
Australia
Date submitted for ethics approval [1] 302640 0
27/02/2019
Approval date [1] 302640 0
Ethics approval number [1] 302640 0

Summary
Brief summary
This trial examines the safety and efficacy of a (relatively) new haemodialysis membrane in the setting of extended hours (nocturnal) haemodialysis, compared to an existing, commonly used membrane. The company has no data on the toxin clearance with this membrane in this setting. Extended hours dialysis offers improved clearances of toxins, compared to conventional 4-hour dialysis, hence it is appropriate to assess the performance of these membranes in the setting of nocturnal HD/Extended hours HD. Both dialysis membranes used are commercially available.
Outcome measures include clearances for uremic toxins (eg. urea, creatinine, phosphate, and indoxyl sulfate) and safety measures such as haematology indices: - full-blood examination and clotting, and biocompatibility indices (Interleukin-6 - known as IL-6).
Trial website
N/A
Trial related presentations / publications
Nil, as yet.
Public notes

Contacts
Principal investigator
Name 90906 0
Prof Peter KERR
Address 90906 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168
Country 90906 0
Australia
Phone 90906 0
+61395943524
Fax 90906 0
+61395946530
Email 90906 0
peter.kerr@monash.edu
Contact person for public queries
Name 90907 0
Prof Peter KERR
Address 90907 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168
Country 90907 0
Australia
Phone 90907 0
+61395943524
Fax 90907 0
+61395946530
Email 90907 0
peter.kerr@monash.edu
Contact person for scientific queries
Name 90908 0
Prof Peter KERR
Address 90908 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168
Country 90908 0
Australia
Phone 90908 0
+61395943524
Fax 90908 0
+61395946530
Email 90908 0
peter.kerr@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
small pilot with internal hospital data only.
What supporting documents are/will be available?
Study protocol
Summary results
No Results