None listed
Conditions
Brief summary
The purpose of the study is to look at the effect of 3 registered phosphate binder on serum calci-protein particle formation. It is hypothesised that formation of these particles may link inflammation with vascular stiffening and calcification. In turn the class of phosphate binder used my impact the quantity of these particles produced.
Interventions
Calcium carbonate (oral (600mg tablets), up to 3 tablets three times a day) treatment for 12 weeks followed by randomisation to either : Calcium Carbonate, oral (800 mg tablets), up to 3 tablets three times a day Sevelamer Hydrochloride, oral (800 mg tablets), up to 3 tablets three times a day Sevelamer Carbonate, oral, up to 3 tablets three times a day for a period of 24 weeks. Starting dose when changing from calcium carbonate to either Sevelamer carbonate or Sevelamer hydrochloride is based on the number of tablets taken, 1 tablet of calcium carbonate is considered to be equivalent to 1 tablet of Sevelamer carbonate/hydrochloride in terms of binding phosphate in the gastrointestinal tract. Participants will commence the new medication taking the same number of tablets daily as they were on previously. Dosing is dependent participant's serum phosphate level and is targeted to a serum phosphate <2.0 mmol/L. Phosphate is monitored every 4 weeks in line with standard of care, study drug dose remains unchanged unless there is indication of hypo or hyper phophataemia. If serum phosphate is <0.8 mmol/L decrease dose by 1 tablet per day. Participant is withdrawn if serum phosphate is <0.8 m mol/L and not on phosphate binder medication. If serum phosphate is <0.6 mmol/L then all phosphate binders should cease and level should be checked in 3 days. If serum phosphate is above 2.6 mmol/L on maximum dose of phosphate binder (Calcium carbonate > 5.4 g/day (i.e. 9 X 600 mg tablets); Sevelamer HCL > 7.2 g/day (i.e. 9 X 800 mg tablets); Sevelamer carbonate >7.2 g/day (i.e. 9 X 800 mg tablets )then participant should be withdrawn from the study. Compliance will be monitored by package returns.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients receiving haemodialysis treatment
Exclusion criteria
Uncontrolled plasma phosphate (>2.6 mmol/L) Cinacalcet use Patients likely to have a parathyroidectomy Allergy or intolerance to sevelamer or calcium carbonate Lower limb amputation History of calciphylaxis