CompletedPhase 3Phase 4ACTRN12610000650099

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.


Sponsor

Australasian Kidney Trials Network (University of Qld)

Enrollment

488 participants

Start Date

Mar 19, 2012

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

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

lanthanum carbonate (500mg 3x daily) administration: chewable (oral) tablets duration of treatment: 24 months


Locations(12)

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,SA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,QLD,SA,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,SA,VIC, Australia

Concord Repatriation Hospital - Concord

NSW,QLD,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,VIC, Australia

Western Hospital - Footscray

NSW,QLD,SA,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,QLD,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,VIC, Australia

Logan Hospital - Meadowbrook

NSW,QLD,SA,VIC, Australia

Otago, New Zealand

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ACTRN12610000650099