Outcome study of Lanthanum Carbonate compared with Calcium carbonate on cardiovascular mortality and morbidity in patients with chronic kidney disease on hemodialysis: Landmark Study

Outcome study of Lanthanum Carbonate compared with Calcium carbonate on cardiovascular mortality and morbidity in patients with chronic kidney disease on hemodialysis: Landmark Study - Outcome study of Lanthanum Carbonate compared with Calcium carbonate in hemodialysis patients: Landmark Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006815

Enrollment

3000

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 (Patients will be followed for three years after the last patient is enrolled ) Calcium carbonate treatment (Patients will be followed for three years after the last pati

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
Cardiovascular event free survival time Following diseases were recognized; 1) death due to cardiovascular diseases including sudden cardiac death 2) nonfatal myocardial infarction 3) nonfatal cerebral stroke including transient ischemic attack, TIA 4) unstable angina 5) hospitalization for heart failure 6) hospitalization for ventricular arrhythmia	—

Secondary

Measure	Time frame
- overall survival - secondary hyperparathyroidism free survival - hip fracture free survival - quality of life questionnaire (KDQOL-SF, v1.3) - bone mineral density (DEXA)	—

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