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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02237534
Other study ID # CKDR-002
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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 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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