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

Phase 4

• Conditions: Hyperphosphatemia; Renal Insufficiency, Chronic; Bone Diseases, Metabolic
• Interventions: Drug: Lanthanum carbonate; Drug: Calcium Carbonate

• Registration Number: NCT02237534
• Lead Sponsor: Osaka University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lanthanum carbonate	Lanthanum carbonate	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.
Calcium carbonate	Calcium Carbonate	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.

Primary Outcome Measures

Name	Time	Method
Coronary artery calcification score	1 year

Secondary Outcome Measures

Name	Time	Method
Serum osteoprotegerin concentration	1 year
Serum bone metabolic markers	1 year	Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time	Up to 1 year
Estimated glomerular filtration rate over time	Up to 1 year
Bone mineral density	1 year
Cardiovascular event requiring hospitalization	Up to 1 year	Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease
Death	Up to 1 year
Endothelial function	3 months	Measured by EndoPAT™ (Itamar Medical Ltd.)
Urinary alpha-Klotho to creatinine ratio	1 year
End-stage renal disease requiring renal replacement therapy	Up to 1 year
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio	1 year

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan