Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia (LAVALIER)

Osaka University

Status and phase: Unknown; Phase 4

Conditions: Bone Diseases, Metabolic; Hyperphosphatemia; Renal Insufficiency, Chronic

Treatments: Drug: Calcium Carbonate; Drug: Lanthanum carbonate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02237534

CKDR-002

Details and patient eligibility

About

The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
• With written informed consent

Exclusion criteria

• History of cardiac surgery
• With coronary artery stent
• Polycystic kidney disease
• Hypothyroidism
• On treatment with lanthanum carbonate
• History of admission within 3 months
• History of ileus
• Severe liver dysfunction
• Severe gastrointestinal dysfunction
• Allergy to lanthanum carbonate or calcium carbonate
• Pregnant or breastfeeding women
• Judged as ineligible by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Calcium carbonate

Active Comparator group

Description:

Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration \<4.5 mg/dL. Maximum dose is 3,000 mg/day.

Treatment:

Drug: Calcium Carbonate

Lanthanum carbonate

Experimental group

Description:

Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration \<4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.

Treatment:

Drug: Lanthanum carbonate