Lanthanum Versus Calcium Carbonate for Patients With CKD

JRCT ID: jRCTs051180055

Registered date:12/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-dialysis chronic kidney disease
• Date of first enrollment: 10/10/2014
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Active Comparator: Calcium carbonate
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.
Experimental: Lanthanum carbonate
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.

Outcome(s)

• Primary Outcome: Coronary artery calcification score at 1 year after the study initiation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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
• Exclude 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

Related Information

• Primary Sponsor: Sakaguchi Yusuke
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd.,Grant for pathophysiological research conference in chronic kidney disease
• Secondary ID(s): UMIN000035527