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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

Condition category

Condition code

Renal and Urogenital

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]

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]

Aortic vascular calcification measured by computed tomography (CT) scan

Timepoint [1]

12 months

Secondary outcome [1]

Changes in mineral metabolism (measured by serum calcium, phosphate, parathyroid hormone (PTH) and calcium-phosphate product (CaxP))

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3168

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Roche Pharmaceuticals (Neorecormon Research Grant)

Address [1]

4-10 Inman Road
Dee Why NSW 2099
Australia

Country [1]

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]

Hospital

Name [1]

Royal Melbourne Hospital

Address [1]

Gratton Street
Parkville Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health Research Ethics Committee

Ethics committee address [1]

Monash Medical Centre
246 Clayton Road, Clayton 3168 Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/01/2008

Approval date [1]

Ethics approval number [1]

*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

Address

Country

Phone

Fax

Contact person for public queries

Name

Nigel Toussaint

Address

Department of Nephrology
Monash Medical Centre
246 Clayton Road, Clayton 3168 Victoria

Country

Australia

Phone

+61 3 9594 3072

Fax

[email protected]

Contact person for scientific queries

Name

Nigel Toussaint

Address

Department of Nephrology
Monash Medical Centre
246 Clayton Road, Clayton 3168 Victoria

Country

Australia

Phone

+61 3 9594 3072

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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