Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary Study

Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary Study - Randomized trial on the effects of Lanthanum Carbonate on coronary artery calcification: Landmark-SS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006816

Enrollment

400

Registered

2011-12-01

Start date

2011-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis patients with hyperphosphatemia

Interventions

Lanthanum carbonate treatment (Follow-up: 2 years) Calcium carbonate treatment (Follow-up: 2 years)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - hemodialysis patients with hyperphosphatemia who require phosphate binders - hemodialysis for more than 3 months - patients who have at lease one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus) - intact-PTH > or =240 pg/mL - life expectancy > 1 year - with written informed consent

Exclusion criteria

Exclusion criteria: - contraindications to Ca carbonate and La carbonate - swallowing disorders - severe GI disorders - history of obstructed bowels - history of IHD/stroke within 6 months - NYHA classification III-IV - severe liver dysfunction, AST or ALT greater than 3 times the upper limit of institution - require treatment of arrthythmia - severe malnutrition - malignancy of any type within the last 5 years - peritoneal dialysis patients - pregnant or possibly pregnant women or women on lactation and plan to get pregnant within study term - ineligible patients according to the investigator's judgment

Design outcomes

Primary

Measure	Time frame
Change in coronary artery calcification score (Agatston Score) by MDCT for 2 years	—

Secondary

Measure	Time frame
-Percent change from baseline in Agatston Score - Change in serum phosphate - Change in serum adjusted calcium - Change oin intact-PTH	—

Countries

Japan

Contacts

Public ContactHiroaki Ogata

Showa University Northern Yokohama Hospital Department of Internal Medicine

ogatah@med.showa-u.ac.jp+81-45-949-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026