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Trial registered on ANZCTR


Registration number
ACTRN12615000517572
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
22/05/2015
Date last updated
30/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two dialysis modes: nocturnal haemodialysis (NHD) and haemodiafiltration (HDF) in haemodialysis patients.
Scientific title
The effect of nocturnal haemodialysis (NHD) and haemodiafiltration (HDF) on the biochemical profile of haemodialysis patients.
Secondary ID [1] 286651 0
nil
Universal Trial Number (UTN)
U1111-1169-9356
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
haemodialysis 294983 0
Condition category
Condition code
Renal and Urogenital 295248 295248 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2X2 Crossover study - comparison of 2 different dialysis membranes plus comparison of NHD vs HDF.

Baseline status (prior to first study treatment): Nocturnal haemodialysis (8 hour sessions, 3.5x per week) - performed at home, using Fresenius Cordiax dialysers.

Randomisation 1: randomised to either remain on the Fresenius Cordiax dialysers OR to change to Nipro Elisio dialysers - of similar surface area.

Randomisation 2: enter cross-over trial of either NHD followed by HDF or vice versa; both with a 2 week washout (regular nocturnal HD) in between.
The study session will be the last dialysis session of each 2-week study period (NHD and HDF): for NHD this study session will be performed in the Home training unit.
Trial comparator: Haemodiafiltration (4 hour sessions, 3x per week) - performed in the Home Dialysis Training Unit under nurse supervision.
Study periods are 2 weeks each, with the last session in the 2-week period being the tested session. There is a 2 week washout between the two periods, wherein patients return to their baseline (NHD) treatment pattern.

For the 2-week NHD study period, patients will have 3x per week dialysis (rather than 3.5x) to allow closer comparison.


Intervention code [1] 291795 0
Treatment: Other
Comparator / control treatment
Nocturnal haemodialysis - 8 hour, overnight dialysis sessions at 250 ml/min blood flow and 300 ml/min dialysate flow - 3 - 3.5 times per week. Performed without supervision at home; except for the final study session which will be performed in the Dialysis Unit.

The patients will usually be using the Fresenius membrane prior to the study. The Nipro Elisio dialyser will be considered the comparator membrane.
Control group
Active

Outcomes
Primary outcome [1] 294996 0
serum biochemical parameters of dialysis adequacy (urea, phosphate, B2microglobulin, retinol binding protein, fetuin, FGF-23, alpha-1 microglobulin) as a composite outcome
Timepoint [1] 294996 0
Biochemical assessment at baseline and at the end of 2 weeks of each treatment option.
Primary outcome [2] 295038 0
dialysate based assessment of removal of urea and phosphate
Timepoint [2] 295038 0
baseline and at the end of each 2-week treatment phase.
Secondary outcome [1] 314548 0
cardiovascular stability - as assessed by blood pressure during dialysis.
Timepoint [1] 314548 0
during the last dialysis session of each 2-week treatment phase.

Eligibility
Key inclusion criteria
existing nocturnal haemodialysis patients
have been stable on NHD for at least 3 months
permanent vascular access
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
planned transplant
not able to provide consent
not able to adhere to protocol

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)
recruitment from existing nocturnal HD cohort
random allocation to membrane type and cross-over sequence using computer generated randomisation program by team member not involved in recruitment.
(2x2 trial - membrane type as well as NHD vs HDF sequence)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random allocation protocol by third party
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
2 x 2 also assessing membrane type
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
group comparisons of biochemical endpoints.
This is a pilot study.
The only other published study involved 8 patients examined over a single dialysis.

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
Recruitment hospital [1] 3755 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 291227 0
Commercial sector/Industry
Name [1] 291227 0
Nipro Japan
Address [1] 291227 0
Nipro - Global Business Division
3-9-3 Honjo-Nishi Kita-Ku
Osaka 531-8510
JAPAN
Country [1] 291227 0
Japan
Funding source category [2] 291228 0
Hospital
Name [2] 291228 0
Monash Medical Centre Department of Nephrology
Address [2] 291228 0
Monash Medical Centre
246 Clayton Rd
Clayton, 3168
Vic, Australia
Country [2] 291228 0
Australia
Primary sponsor type
Individual
Name
Prof Peter Kerr
Address
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168
Country
Australia
Secondary sponsor category [1] 289903 0
Individual
Name [1] 289903 0
A/Prof Kevan Polkinghorne
Address [1] 289903 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168
Country [1] 289903 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292787 0
Monash Health
Ethics committee address [1] 292787 0
Monash Medical Centre
246 Clayton Rd
Clayton, 3168
Victoria
Ethics committee country [1] 292787 0
Australia
Date submitted for ethics approval [1] 292787 0
Approval date [1] 292787 0
10/04/2015
Ethics approval number [1] 292787 0
15011L

Summary
Brief summary
This study examines the biochemical effects of two different dialysis modes. Surprisingly, this has not been well covered in the literature, despite both modes having been practiced for 20+ years.
As a secondary feature it also compares two different dialysis membranes utilised in these dialysis modes.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57026 0
Prof Peter Kerr
Address 57026 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd,
Clayton, 3168, Vic
Country 57026 0
Australia
Phone 57026 0
+61 3 9594-3524
Fax 57026 0
+61 3 9594 6530
Email 57026 0
peter.kerr@monash.edu
Contact person for public queries
Name 57027 0
Prof Peter Kerr
Address 57027 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd,
Clayton, 3168, Vic
Country 57027 0
Australia
Phone 57027 0
+61 3 9594 3524
Fax 57027 0
Email 57027 0
peter.kerr@monash.edu
Contact person for scientific queries
Name 57028 0
Prof Peter Kerr
Address 57028 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd,
Clayton, 3168, Vic
Country 57028 0
Australia
Phone 57028 0
+61 3 9594 3524
Fax 57028 0
Email 57028 0
peter.kerr@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