IMPROVE: IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease
A randomised, double-blind, placebo-controlled trial to assess the effect of phosphate reduction with lanthanum carbonate on arterial compliance and vascular calcification in patients with chronic kidney disease stages 3b-4.
Australasian Kidney Trials Network (University of Qld)
488 participants
Mar 19, 2012
Interventional
Conditions
Summary
The main objective of the study is to determine whether use of a phosphate binder (lanthanum carbonate) in subjects with chronic kidney disease (CKD) stages 3b and 4 will reduce the risk and burden of cardiovascular disease. Patients with CKD 3b and 4 have a substantially higher incidence of cardiovascular disease contributing to significant morbidity and mortality. Phosphate imbalance is a putative non-traditional risk factor for cardiovascular disease in this population (association studies) and lowering of serum phosphate levels with a phosphate binder may be associated with reduced morbidity and mortality. The use of lanthanum carbonate to reduce phosphate and calcium-phosphate product may improve arterial compliance and attenuate the development and/or progression of vascular calcification, reduce the incidence of secondary hyperparathyroidism, and potentially reduce the rate of CKD progression.
Eligibility
Inclusion Criteria1
- Patients with Chronic Kidney Disease (CKD) Stages 3b-4 (eGFR between 15-44ml/ min/1.73m2) 2. Serum phosphate level greater than 1.00mmol/L on at least 1 occasion over the previous 6 months.
Exclusion Criteria8
- Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study
- Renal transplantation
- Recent (within 1 month) hospitalisation or cardiovascular event
- Pregnancy or breast feeding
- Medical conditions that impact on phosphate metabolism (apart from CKD), eg. primary hyperparathyroidism or hypoparathyroidism; previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as Crohn’s disease, ulcerative colitis, coeliac disease or severe liver dysfunction
- Malnutrition, defined as serum albumin <30g/L
- Presence of atrial fibrillation
- Inability to obtain a pulse wave velocity
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Interventions
lanthanum carbonate (500mg 3x daily) administration: chewable (oral) tablets duration of treatment: 24 months
Locations(12)
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ACTRN12610000650099