Renal Insufficiency, Chronic Clinical Trial
— LAVALIEROfficial title:
Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
Verified date | February 2021 |
Source | Osaka University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Osaka University Hospital | Suita | Osaka |
Lead Sponsor | Collaborator |
---|---|
Osaka University | Bayer |
Japan,
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 EndoPATâ„¢ (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 |
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