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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000650099
Acronym
IMPROVE-CKD Trial
Enrollment
278
Registered
2010-08-10
Start date
2012-03-19
Completion date
2017-01-20
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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) 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.

Interventions

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

Sponsors

Australasian Kidney Trials Network (University of Qld)
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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 Crohn’s disease, ulcerative colitis, coeliac disease or severe liver dysfunction 6. Malnutrition, defined as serum albumin <30g/L 7. Presence of atrial fibrillation 8. Inability to obtain a pulse wave velocity

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026