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

Sponsor

Osaka University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02237534

Collaborator

Bayer (Industry)

Enrollment

Location

Arms

108

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic Hyperphosphatemia Bone Diseases, Metabolic	Drug: Lanthanum carbonate Drug: Calcium Carbonate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Calcium Carbonate
Experimental: 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.	Drug: Lanthanum carbonate Other Names: FOSRENOL®

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Calcium Carbonate

Experimental: 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.

Drug: Lanthanum carbonate

Other Names:

FOSRENOL®

Outcome Measures

Primary Outcome Measures

Coronary artery calcification score [1 year]

Secondary Outcome Measures

Endothelial function [3 months]
Measured by EndoPAT™ (Itamar Medical Ltd.)
Serum bone metabolic markers [3 months]
Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
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]
Serum osteoprotegerin concentration [3 month]
Serum osteoprotegerin concentration [1 year]
Urinary alpha-Klotho to creatinine ratio [3 months]
Urinary alpha-Klotho to creatinine ratio [1 year]
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio [3 months]
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio [1 year]
End-stage renal disease requiring renal replacement therapy [Up to 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]