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

NCT ID: NCT01578200

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-24

Study Completion Date

2019-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemodialysis Hyperphosphatemia

Keywords

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CKD-MBD phosphate-binder vascular calcification mortality dialysis Hemodialysis patients with hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lanthanum carbonate

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

Group Type EXPERIMENTAL

Lanthanum Carbonate

Intervention Type DRUG

Calcium Carbonate

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

Group Type ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type DRUG

Interventions

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Lanthanum Carbonate

Intervention Type DRUG

Calcium Carbonate

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa University School of Medicine

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tadao Akizawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Showa University

Locations

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Showa University

Shinagawa, Tokyo, Japan

Site Status

Countries

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Japan

References

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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Ogata H, Fukagawa M, Hirakata H, Kagimura T, Fukushima M, Akizawa T; LANDMARK Investigators and Committees. Effect of Treating Hyperphosphatemia With Lanthanum Carbonate vs Calcium Carbonate on Cardiovascular Events in Patients With Chronic Kidney Disease Undergoing Hemodialysis: The LANDMARK Randomized Clinical Trial. JAMA. 2021 May 18;325(19):1946-1954. doi: 10.1001/jama.2021.4807.

Reference Type DERIVED
PMID: 34003226 (View on PubMed)

Other Identifiers

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UMIN000006815

Identifier Type: REGISTRY

Identifier Source: secondary_id

TRIGU1111

Identifier Type: -

Identifier Source: org_study_id