Clinical trial NCT02237534: Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Official title: Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Hyperphosphatemia
Bone Diseases, Metabolic
Keywords: Lanthanum
Calcium Carbonate
Vascular Calcification
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Coronary artery calcification score
timeFrame: 1 year
Secondary outcomes:
measure: Endothelial function
timeFrame: 3 months
measure: Serum bone metabolic markers
timeFrame: 3 months
measure: Serum bone metabolic markers
timeFrame: 1 year
measure: Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time
timeFrame: Up to 1 year
measure: Estimated glomerular filtration rate over time
timeFrame: Up to 1 year
measure: Bone mineral density
timeFrame: 1 year
measure: Serum osteoprotegerin concentration
timeFrame: 3 month
measure: Serum osteoprotegerin concentration
timeFrame: 1 year
measure: Urinary alpha-Klotho to creatinine ratio
timeFrame: 3 months
measure: Urinary alpha-Klotho to creatinine ratio
timeFrame: 1 year
measure: Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
timeFrame: 3 months
measure: Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
timeFrame: 1 year
measure: End-stage renal disease requiring renal replacement therapy
timeFrame: Up to 1 year
measure: Cardiovascular event requiring hospitalization
timeFrame: Up to 1 year
measure: Death
timeFrame: Up to 1 year
Other outcomes:
measure: Micro RNA array
timeFrame: 1 year
measure: Hypercalcemia
timeFrame: Up to 1 year
measure: Hypocalcemia
timeFrame: Up to 1 year
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
name: Takayuki Hamano, MD, PhD
role: STUDY_CHAIR
References: