IMPROVE: IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease
Australasian Kidney Trials Network, The University of QueenslandDataset description
Data from: 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.Identifiers
Source Study
Trial name (public)
IMPROVE: IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney DiseaseTrial acronym
IMPROVE-CKD Trial
Trial ID
ACTRN12610000650099
Purpose
Treatment
Phase
Phase 3 / Phase 4
Funding
Commercial sector/Industry,SHIRE PHARMACEUTICAL DEVELOPMENT LIMITED
Scientific enquiries
Dr Nigel Toussaint
Brief 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) a .... Read more
Key Inclusion Criteria
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.
Key Exclusion Criteria
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
Can healthy volunteers participate?
No
Population
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
Intervention code Treatment: Drugs
lanthanum carbonate (500mg 3x daily) administration: chewable (oral) tablets duration of treatment: 24 months
Comparison
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
Outcomes
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
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
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.
When will data be available?
Beginning 2 years and ending 5 years following main publication.
Available to whom?
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Available for what types of analyses?
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.