IMPROVE-CKD Trial
ACTRN12610000650099
Treatment
Phase 3 / Phase 4
Commercial sector/Industry,SHIRE PHARMACEUTICAL DEVELOPMENT LIMITED
Dr Nigel Toussaint
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) a .... Read more
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.
1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study 2. Renal transplantation 3. Recent (within 1 month) hospitalisation or cardiovascular event 4. Pregnancy or breast feeding 5. Medical conditions that impact on phosphate metabolism (apart from CKD), eg. primary hyperparathyroidism or hypoparathyroidism; previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as .... Read more
No
Sample Size 278
Min. age 18 Years
Max. age 0 No limit
Sex Both males and females
Condition category Phosphate imbalance (as a risk factor for cardiovascular disease) in patients with Chronic Kidney Disease
Condition code Cardiovascular , Renal and Urogenital
Intervention code Treatment: Drugs
lanthanum carbonate (500mg 3x daily) administration: chewable (oral) tablets duration of treatment: 24 months
Control group Placebo
matched placebo (3x daily) administration: chewable tablets duration of treatment: 24 months Placebo that is undistingishable from the active treatment but containing no active ingredients
Outcome: Arterial compliance (measured by pulse wave velocity) as a surrogate marker of cardiovascular morbidity and mortalityTimepoint: At baseline and at 6 months, 12 months, 18 months and 24 months post randomisation
yes
Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
Beginning 2 years and ending 5 years following main publication.
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.