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

This study is currently recruiting participants.
Verified December 2012 by Translational Research Informatics Center, Kobe, Hyogo, Japan
Sponsor:
Collaborator:
Showa University School of Medicine
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01578200
First received: April 13, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemodialysis
Hyperphosphatemia
 Drug: Lanthanum Carbonate, Calcium Carbonate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Cardiovascular event free survival time. [ Time Frame: 3 years ]

    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


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ]
  • Secondary hyperparathyroidism free survival [ Time Frame: 3 years ]
  • Hip fracture free survival [ Time Frame: 3 years ]
  • Quality of life questionnaire (KDQOL-SF, v1.3) [ Time Frame: 3 years ]
  • Bone mineral density (DEXA) [ Time Frame: 3 years ]

Estimated Enrollment: 3000
Study Start Date: December 2011
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lanthanum carbonate Drug: Lanthanum Carbonate, Calcium Carbonate
Active Comparator: Calcium carbonate Drug: Lanthanum Carbonate, Calcium Carbonate

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 plant to get pregnant within study term
  • ineligible patients according to the investigator's judgment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578200

Contacts
Contact: Hiroaki Ogata, MD, PhD +81-45-949-7000 ogatah@ｍed.showa-u.ac.jp

Locations
Japan
Showa University Recruiting
Shinagawa, Tokyo, Japan, 142-0064
Contact: Hiroaki Ogata, MD, PhD     +81-45-949-7000     ogatah@ｍed.showa-u.ac.jp    
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Showa University School of Medicine
Investigators
Principal Investigator: Tadao Akizawa, MD, PhD Showa University
  More Information

No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01578200     History of Changes
Other Study ID Numbers: TRIGU1111, UMIN000006815
Study First Received: April 13, 2012
Last Updated: December 12, 2012
Health Authority: Japan:Institutional Review Board, Showa University School of Medicine

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
CKD-MBD
phosphate-binder
vascular calcification
 mortality
dialysis
Hemodialysis patients with hyperphosphatemia

Additional relevant MeSH terms:
Hyperphosphatemia
Renal Insufficiency, Chronic
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013