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

Renal Insufficiency, Chronic Clinical Trial

— LAVALIER  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02237534
• Other study ID #: CKDR-002
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: September 2023

Study information

• Verified date: February 2021
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: September 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Hyperphosphatemia
• Metabolic Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lanthanum carbonate

• Calcium Carbonate

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Micro RNA array		1 year
Other	Hypercalcemia	Corrected serum calcium concentration =11.0 mg/dL	Up to 1 year
Other	Hypocalcemia	Corrected serum calcium concentration <8.5 mg/dL	Up to 1 year
Primary	Coronary artery calcification score		1 year
Secondary	Endothelial function	Measured by EndoPAT™ (Itamar Medical Ltd.)	3 months
Secondary	Serum bone metabolic markers	Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)	3 months
Secondary	Serum bone metabolic markers	Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)	1 year
Secondary	Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time		Up to 1 year
Secondary	Estimated glomerular filtration rate over time		Up to 1 year
Secondary	Bone mineral density		1 year
Secondary	Serum osteoprotegerin concentration		3 month
Secondary	Serum osteoprotegerin concentration		1 year
Secondary	Urinary alpha-Klotho to creatinine ratio		3 months
Secondary	Urinary alpha-Klotho to creatinine ratio		1 year
Secondary	Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio		3 months
Secondary	Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio		1 year
Secondary	End-stage renal disease requiring renal replacement therapy		Up to 1 year
Secondary	Cardiovascular event requiring hospitalization	Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease	Up to 1 year
Secondary	Death		Up to 1 year