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

This study is ongoing, but not recruiting participants.
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: August 21, 2014
Last verified: August 2014
  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
Drug: 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:


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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Secondary hyperparathyroidism free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Hip fracture free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality of life questionnaire (KDQOL-SF, v1.3) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Bone mineral density (DEXA) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 2309
Study Start Date: December 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 planned to get pregnant within study term
  • ineligible patients according to the investigator's judgment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578200

Locations
Japan
Showa University
Shinagawa, Tokyo, Japan, 142-0064
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: August 21, 2014
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 August 27, 2014