Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000057381
Ethics application status
Approved
Date submitted
24/01/2008
Date registered
30/01/2008
Date last updated
30/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Dialysate calcium study in alternate night nocturnal haemodialysis
Scientific title
A randomised controlled trial of high versus low dialysate calcium concentrations to assess aortic calcification and changes in mineral metabolsim in alternate night nocturnal haemodialysis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dialysis 2759 0
Condition category
Condition code
Renal and Urogenital 2912 2912 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low dialysate calcium bath (1.3mmol/L) administered during haemodialysis (alternate nightly) for 12 months
Intervention code [1] 2498 0
Treatment: Other
Comparator / control treatment
High dialysate calcium bath (>1.6mmol/L) administered during haemodialysis (alternate nightly) for 12 months
Control group
Dose comparison

Outcomes
Primary outcome [1] 3771 0
Aortic vascular calcification measured by computed tomography (CT) scan
Timepoint [1] 3771 0
12 months
Secondary outcome [1] 6372 0
Changes in mineral metabolism (measured by serum calcium, phosphate, parathyroid hormone (PTH) and calcium-phosphate product (CaxP))
Timepoint [1] 6372 0
12 months

Eligibility
Key inclusion criteria
Subjects receiving renal replacement therapy in the form of haemodialysis at home, alternate night nocturnal haemoialysis (NHD) (3.5nights/week)

Subjects must be 18-80 years of age

Willingness to provide written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects unable to give informed consent or whom have an expected life-span of less than 3 months

Subjects already scheduled to have a kidney transplant from a known living donor

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 will involve haemodialysis patients on NHD recruited from the respective institutions
Allocation will be by sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 558 0
3168

Funding & Sponsors
Funding source category [1] 3011 0
Commercial sector/Industry
Name [1] 3011 0
Roche Pharmaceuticals (Neorecormon Research Grant)
Country [1] 3011 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
Department of Nephrology
246 Clayton Road, Clayton 3168 Victoria
Country
Australia
Secondary sponsor category [1] 2714 0
Hospital
Name [1] 2714 0
Royal Melbourne Hospital
Address [1] 2714 0
Gratton Street
Parkville Victoria
Country [1] 2714 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4968 0
Southern Health Research Ethics Committee
Ethics committee address [1] 4968 0
Monash Medical Centre
246 Clayton Road, Clayton 3168 Victoria
Ethics committee country [1] 4968 0
Australia
Date submitted for ethics approval [1] 4968 0
01/01/2008
Approval date [1] 4968 0
Ethics approval number [1] 4968 0
*07200C

Summary
Brief summary
Elevated calcium phosphate product (Ca x P) is an independent risk factor for vascular calcification and cardiovascular death in the end-stage renal disease (ESRD) population (Block et al, 1998). Conventional haemodialysis (4hrs x 3) may not successfully correct the profound disturbances in calcium and phosphate metabolism of ESRD, characterised by hyperphosphatemia and abnormal serum calcium levels. In general a low calcium dialysate (1.3 mmol/L) is used for patients on conventional haemodialysis in North West Dialysis Service (NWDS), at Monash Medical Centre (MMC) and Geelong Hospital and throughout Australia.

The calcium and phosphate balance achieved with Quotidian Nocturnal Haemodialysis (8 hours x 6 days) differs significantly from conventional haemodialysis and is associated with marked improvements in the reduction of elevated serum phosphate levels. An observational study by Lindsay et al demonstrated that patients on quotidian haemodialysis utilising 1.25 mmol/L dialysate calcium exhibited calcium depletion and hypocalcemia thus exacerbating secondary hyperparathyroidism (Lindsay et al, 2003). In the same study they demonstrated that an increase in dialysate calcium concentration was associated with a return of bone alkaline phosphatase levels to baseline and a gradual fall of parathyroid hormone (PTH) levels to target range. In association with the increase in dialysate calcium, the use of activated vitamin D compounds fell.

Based on the results of this study, it has been common practice to dialyse all nocturnal haemodialysis patients, regardless of whether they dialyse for 8 hrs x 6 or 8 hrs x 3.5, on higher calcium baths (>1.6 mmol/L). It is not clear however, what should be the optimal calcium bath for patients on 8 x 3.5nights/week, particularly as serum phosphate levels are not as tightly controlled with quotidian haemodialysis, and unlike the 6 nights/week group, many patients still require the use of calcium based phosphate binders. Ideally the optimal calcium bath should be such that the overall Ca x P product is <4mmol2/l2 and the PTH 15-30pmol/l, however the concern is that the use of a higher calcium bath in the alternate night group will lead to relative hypercalcemia and an overall increase in Ca x P. Recent evidence also supports the importance of the pleiotropic effects of Vitamin D in addition to its well-recognised role in bone metabolism. It is conceivable that patients being dialysed with a higher calcium bath may not be able to tolerate the addition of Vitamin D due to the development of hypercalcemia.
In order to establish the optimal calcium bath in patients on alternate night haemodialysis, we propose a prospective observational study comparing predefined outcomes using >1.6mmol/L and 1.3mmol/L dialysate calcium.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28326 0
Address 28326 0
Country 28326 0
Phone 28326 0
Fax 28326 0
Email 28326 0
Contact person for public queries
Name 11483 0
Nigel Toussaint
Address 11483 0
Department of Nephrology
Monash Medical Centre
246 Clayton Road, Clayton 3168 Victoria
Country 11483 0
Australia
Phone 11483 0
+61 3 9594 3072
Fax 11483 0
Email 11483 0
[email protected]
Contact person for scientific queries
Name 2411 0
Nigel Toussaint
Address 2411 0
Department of Nephrology
Monash Medical Centre
246 Clayton Road, Clayton 3168 Victoria
Country 2411 0
Australia
Phone 2411 0
+61 3 9594 3072
Fax 2411 0
Email 2411 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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