Data

IMPROVE: IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease

Australasian Kidney Trials Network, The University of Queensland

Dataset 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.
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Source Study

Trial 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 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 ....
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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 ....
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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 mortality
Timepoint: At baseline and at 6 months, 12 months, 18 months and 24 months post randomisation

Data Dictionary: Not Available

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.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au