anthanum Versus Calcium Carbonate for Patients With CKD

Not Applicable

• Conditions: non-dialysis chronic kidney disease

• Registration Number: JPRN-jRCTs051180055
• Lead Sponsor: Sakaguchi Yusuke

Brief Summary

We did not find a significant difference between lanthanum carbonate and calcium carbonate in the progression of coronary artery calcification during 1-year study period among patients with CKD.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-12
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

(1) 20 Years and older (2) Hyperphosphatemia (For patients without calcium carbonate, 4.5- mg/dL) (For Patients with calcium carbonate, 4.0- mg/dL) (3) With written informed consent

Exclusion Criteria

(1) History of cardiac surgery and/or coronary artery stenting (2) Polycystic kidney disease (3) Hypothyroidism (4) On treatment with lanthanum carbonate (5) History of admission within 3 months (6) History of ileus (7) Severe gastrointestinal dysfunction (8) Severe liver dysfunction (9) Allergy to lanthanum carbonate or calcium carbonate (10) Pregnant or breastfeeding women (11) Judged as ineligible by primary physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary artery calcification score at 1 year after the study initiation

Secondary Outcome Measures

Name	Time	Method
1. Vascular endothelial function at 3 months<br>2. Bone turnover markers at 3 and 12 months (BAP, TRACP-5b)<br>3. Time series data about calcium, phosphate, intact PTH, 25(OH)D, and 1,25(OH)2D<br>4. Time series data about eGFR<br>5. Bone mineral density at 12 months<br>6. Osteoprotegerin levels at 3 and 12 months<br>7. Urinary alpha-Klotho and L-FABP levels at 3 and 12 months<br>8. miRNA array data at 12 months<br>9. incidence of the following clinical events<br> 1. hypercalcemia (serum calcium 11.0- mg/dL)<br> 2. hypocalcemia (serum calcium -8.4 mg/dL)<br> 3. end-stage kidney disease requiring renal replacement therapy<br> 4. cardiovascular events(myocardial infarction, angina pectoris, heart failure, stroke, and peripheral artery disease)<br> 5. death