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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Renal Insufficiency, Chronic; Bone Diseases, Metabolic; Hyperphosphatemia
• Intervention / Treatment: Drug: Calcium Carbonate; Drug: Lanthanum carbonate

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coronary artery calcification score	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Measured by EndoPAT™ (Itamar Medical Ltd.)	3 months
Serum bone metabolic markers	Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)	3 months
Serum bone metabolic markers	Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)	1 year
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	Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease	Up to 1 year
Death		Up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Micro RNA array		1 year
Hypercalcemia	Corrected serum calcium concentration ≥11.0 mg/dL	Up to 1 year
Hypocalcemia	Corrected serum calcium concentration <8.5 mg/dL	Up to 1 year

Collaborators and Investigators

• Sponsor: Osaka University
• Collaborators: Bayer
• Investigators: Study Chair: Takayuki Hamano, MD, PhD, Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Vascular Calcification; Lanthanum; Calcium Carbonate
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Musculoskeletal Diseases; Phosphorus Metabolism Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Bone Diseases; Bone Diseases, Metabolic; Metabolic Diseases; Hyperphosphatemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: CKDR-002