Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study (LANDMARK)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Hemodialysis; Hyperphosphatemia

Treatments: Drug: Lanthanum Carbonate; Drug: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01578200

TRIGU1111

UMIN000006815 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.

Full description

Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.

Enrollment: 2,309 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• contraindications to lanthanum carbonate and calcium carbonate
• swallowing disorders
• severe GI disorders
• history of obstructed bowels
• history of IHD/stroke within 6 months before randomization
• NYHA classification Ⅲ-Ⅳ
• severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution
• require treatment of arrhythmia
• severe malnutrition
• malignancy of any type within the last five years
• peritoneal dialysis patients
• pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term
• ineligible patients according to the investigator's judgment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,309 participants in 2 patient groups

Lanthanum carbonate

Experimental group

Description:

Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.

Treatment:

Drug: Lanthanum Carbonate

Calcium Carbonate

Active Comparator group

Description:

Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.

Treatment:

Drug: Calcium Carbonate