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

Primary Purpose

Renal Insufficiency, Chronic, Hyperphosphatemia, Bone Diseases, Metabolic

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Lanthanum carbonate
Calcium Carbonate
Sponsored by
Osaka University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Lanthanum, Calcium Carbonate, Vascular Calcification

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Osaka University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Calcium carbonate

Lanthanum carbonate

Arm 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.

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.

Outcomes

Primary Outcome Measures

Coronary artery calcification score

Secondary Outcome Measures

Endothelial function
Measured by EndoPAT™ (Itamar Medical Ltd.)
Serum bone metabolic markers
Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
Serum bone metabolic markers
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
Estimated glomerular filtration rate over time
Bone mineral density
Serum osteoprotegerin concentration
Serum osteoprotegerin concentration
Urinary alpha-Klotho to creatinine ratio
Urinary alpha-Klotho to creatinine ratio
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
End-stage renal disease requiring renal replacement therapy
Cardiovascular event requiring hospitalization
Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease
Death

Full Information

First Posted
September 9, 2014
Last Updated
February 24, 2021
Sponsor
Osaka University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02237534
Brief Title
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Acronym
LAVALIER
Official Title
Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka University
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Hyperphosphatemia, Bone Diseases, Metabolic
Keywords
Lanthanum, Calcium Carbonate, Vascular Calcification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takayuki Hamano, MD, PhD
Organizational Affiliation
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan

12. IPD Sharing Statement

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

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