Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01578200
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : November 30, 2020
Sponsor:
Collaborator:
Showa University School of Medicine
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hemodialysis Hyperphosphatemia Drug: Lanthanum Carbonate Drug: Calcium Carbonate Phase 3

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 24, 2011
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lanthanum carbonate
Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.
 Drug: Lanthanum Carbonate
Active Comparator: Calcium Carbonate
Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.
 Drug: Calcium Carbonate


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Overall survival [ Time Frame: 3 years ]
  2. Secondary hyperparathyroidism free survival [ Time Frame: 3 years ]
  3. Hip fracture free survival [ Time Frame: 3 years ]
  4. Quality of life questionnaire (KDQOL-SF, v1.3) [ Time Frame: 3 years ]
  5. Bone mineral density (DEXA) [ Time Frame: 3 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 planned to get pregnant within study term
  • ineligible patients according to the investigator's judgment
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578200


Locations
Layout table for location information
Japan
Showa University
Shinagawa, Tokyo, Japan, 142-0064
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Showa University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Tadao Akizawa, MD, PhD Showa University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01578200    
Other Study ID Numbers: TRIGU1111
UMIN000006815 ( Registry Identifier: UMIN Clinical Trials Registry )
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: March 2019
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
CKD-MBD
phosphate-binder
vascular calcification
 mortality
dialysis
Hemodialysis patients with hyperphosphatemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium Carbonate
Calcium
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents