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

NCT01578200 | Completed Phase 3

• 2 other identifiers: TRIGU1111UMIN000006815
• Study Type: interventional
• Target: 2,309
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis; Hyperphosphatemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular event free survival time.

  Cardiovascular event consisting of 1. death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1), 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

  3 years

Secondary Outcomes (5)

• Overall survival

  3 years

• Secondary hyperparathyroidism free survival

  3 years

• Hip fracture free survival

  3 years

• Quality of life questionnaire (KDQOL-SF, v1.3)

  3 years

• Bone mineral density (DEXA)

  3 years

Study Arms (2)

Lanthanum carbonate

EXPERIMENTAL

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

Drug: Lanthanum Carbonate

Calcium Carbonate

ACTIVE COMPARATOR

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

Drug: Calcium Carbonate

Interventions

Lanthanum Carbonate DRUG

Lanthanum carbonate

Calcium Carbonate DRUG

Calcium Carbonate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Showa University School of Medicine: collaborator

Study Sites (1)

Showa University

Shinagawa, Tokyo, 142-0064, Japan

Location

Related Publications (2)

• 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.

  PMID: 40576086 DERIVED

• 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.

  PMID: 34003226 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Chronic Kidney Disease-Mineral and Bone Disorder; Vascular Calcification

Interventions

lanthanum carbonate; Calcium Carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Tadao Akizawa, MD, PhD

  Showa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: December 24, 2011
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: November 30, 2020

Record last verified: 2019-03

Locations

JP (1)