ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000046404

Ethics application status

Not yet submitted

Date submitted

10/01/2007

Date registered

12/01/2007

Date last updated

12/01/2007

Type of registration

Prospectively registered

Titles & IDs

Public title

Randomised Controlled Trial of Lanthanum carbonate vs Calcium carbonate on Vascular Calcification and Arterial Stiffness in Haemodialysis Patients:
A Pilot Study

Scientific title

A Randomised Controlled Trial of Lanthanum carbonate vs Calcium carbonate on Vascular Calcification and Arterial Stiffness in Haemodialysis Patients

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular disease and arterial stiffness in end-stage kidney disease

Condition category

Condition code

Renal and Urogenital

Kidney disease

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomised trial comparing the impact of two different phosphate binders (lanthanum carbonate vs calcium carbonate) on vascular calcification and arterial stiffness in haemodialysis patients over 18 months. Group 1 will receive lanthanum carbonate 750mg three times daily, increasing to max 3750mg daily, and Group 2 will receive calcium carbonate 1500mg three times daily (with equivalent 600mg caclium tds), with increase to max 9 tablets daily, aiming for serum phosphate <1.7 in both groups. Both medications will be administered orally and with meals.

Intervention code [1]

Prevention

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

Changes in vascular calcification as measured by Computed tomography (CT) scans (of aorta and superficial artery)

Timepoint [1]

At 12 months and 18 months

Secondary outcome [1]

Changes in arterial stiffness (measured by pulse wave velocity)

Timepoint [1]

at 3-6 month intervals

Secondary outcome [2]

Changes in bone mineral density

Timepoint [2]

at 18 months

Eligibility

Key inclusion criteria

Patients established on haemodialysis for at least 3 months.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

If expected life-span <3 months; scheduled for renal transplant or parathyroidectomy in next 6 months; active peptic ulcer disease, and ulcerative colitis or Crohn's; and if on daily or nocturnal haemodialysis.

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)

Allocation will occur by concealed envelopes by an associate researcher.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random order generation, using a randomization table created by a computer software (i.e., computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2007

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)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Oprhan Australia (Shire Pharmaceuticals)

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Nephrology, Monash Medical Centre, Clayton

Address

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Orphan Australia (Shire Pharmaceuticals)

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Monash Medical Centre-Southern Health Reasearch and Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Cardiovascular disease (CVD) is the commonest cause of mortality in patients with chronic kidney disease (CKD) and end-stage kidney disease (CKD Stage 5). Reasons for the greater incidence of CVD in this group include traditional CVD risk factors of hypertension, dyslipidemia and diabetes but more importantly also include non-traditional risk factors such as calcium and phosphate imbalance. The latter is thought most likely to contribute to vascular calcification, especially for those on dialysis, and this in turn leads to arterial stiffness and left ventricular hypertrophy, the two commonest cardiovascular complications. Arterial stiffness and calcification have been found to be independent predictors of all-cause and cardiovascular mortality in CKD. 

Pharmacological management to control calcium and phosphate imbalance can reduce vascular calcification and CVD by reducing serum phosphate and PTH. Unfortunately the majority of phosphate binders are calcium based and may contribute to raised serum calcium and worsening calcification. Newer phosphate binders, such as lanthanum carbonate, are non-calcium based and may prove to reduce CVD as well as controlling phosphate balance. 

We aim to perform a prospective, randomised study assessing the impact of lanthanum carbonate on cardiovascular and bone mineral parameters. This will be a single-centre study involving subjects with CKD Stage 5 on haemodialysis. Arterial stiffness (by pulse wave analysis and pulse wave velocity) and vascular calcification (using CT scans through superficial femoral artery and aorta) will be followed as well as serum markers of calcium, phosphate and PTH. Differences in these end-points will be compared between participants taking lanthanum and calcium carbonate. The study will be conducted over an 18 month period and we aim to recruit about 50 patients (25 randomised to lanthanum carbonate and 25 to calcium carbonate).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Nigel Toussaint

Address

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

Country

Australia

Phone

+61 3 9594 3072

Fax

nigel.toussaint@med.monash.edu.au

Contact person for scientific queries

Name

Dr Nigel Toussaint

Address

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

Country

Australia

Phone

+61 3 9594 3072

Fax

nigel.toussaint@med.monash.edu.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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