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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
planned transplant
not able to provide consent
not able to adhere to protocol

Study design
Purpose of the study
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
Other design features
2 x 2 also assessing membrane type
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Country [1] 291227 0
Funding source category [2] 291228 0
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
Primary sponsor type
Prof Peter Kerr
Dept of Nephrology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic, 3168
Secondary sponsor category [1] 289903 0
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

Ethics approval
Ethics application status
Ethics committee name [1] 292787 0
Monash Health
Ethics committee address [1] 292787 0
Monash Medical Centre
246 Clayton Rd
Clayton, 3168
Ethics committee country [1] 292787 0
Date submitted for ethics approval [1] 292787 0
Approval date [1] 292787 0
Ethics approval number [1] 292787 0

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
Trial related presentations / publications
Public notes

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
Phone 57026 0
+61 3 9594-3524
Fax 57026 0
+61 3 9594 6530
Email 57026 0
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
Phone 57027 0
+61 3 9594 3524
Fax 57027 0
Email 57027 0
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
Phone 57028 0
+61 3 9594 3524
Fax 57028 0
Email 57028 0

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