None listed
Conditions
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).
Interventions
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
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.
Sponsors
Department of Nephrology, Monash Medical Centre, Clayton
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients established on haemodialysis for at least 3 months.
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.
Outcome results
None listed