Trial Review

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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 1539 0
Condition category
Condition code
Renal and Urogenital 1637 1637 0 0
Kidney disease
Cardiovascular 1638 1638 0 0
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] 1545 0
Prevention
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2259 0
Changes in vascular calcification as measured by Computed tomography (CT) scans (of aorta and superficial artery)
Timepoint [1] 2259 0
At 12 months and 18 months
Secondary outcome [1] 3935 0
Changes in arterial stiffness (measured by pulse wave velocity)
Timepoint [1] 3935 0
at 3-6 month intervals
Secondary outcome [2] 3936 0
Changes in bone mineral density
Timepoint [2] 3936 0
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?
No
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1783 0
Commercial sector/Industry
Name [1] 1783 0
Oprhan Australia (Shire Pharmaceuticals)
Country [1] 1783 0
Australia
Primary sponsor type
Hospital
Name
Department of Nephrology, Monash Medical Centre, Clayton
Address
Country
Australia
Secondary sponsor category [1] 1590 0
Commercial sector/Industry
Name [1] 1590 0
Orphan Australia (Shire Pharmaceuticals)
Address [1] 1590 0
Country [1] 1590 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3342 0
Monash Medical Centre-Southern Health Reasearch and Ethics Committee
Ethics committee address [1] 3342 0
Ethics committee country [1] 3342 0
Australia
Date submitted for ethics approval [1] 3342 0
Approval date [1] 3342 0
Ethics approval number [1] 3342 0

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 27479 0
Address 27479 0
Country 27479 0
Phone 27479 0
Fax 27479 0
Email 27479 0
Contact person for public queries
Name 10734 0
Dr Nigel Toussaint
Address 10734 0
Department of Nephrology
Monash Medical Centre
246 Clayton Rd, Clayton
Victoria 3168
Country 10734 0
Australia
Phone 10734 0
+61 3 9594 3072
Fax 10734 0
Email 10734 0
[email protected]
Contact person for scientific queries
Name 1662 0
Dr Nigel Toussaint
Address 1662 0
Department of Nephrology
Monash Medical Centre
246 Clayton Rd, Clayton
Victoria 3168
Country 1662 0
Australia
Phone 1662 0
+61 3 9594 3072
Fax 1662 0
Email 1662 0
[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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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