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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 7, 2014
Last verified: February 2014

April 13, 2012
February 7, 2014
December 2011
June 2017   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01578200 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hemodialysis
  • Hyperphosphatemia
  • Drug: Lanthanum Carbonate
  • Drug: Calcium Carbonate
  • Experimental: Lanthanum carbonate
    Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.
    Intervention: 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.
    Intervention: Drug: Calcium Carbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Hiroaki Ogata, MD, PhD +81-45-949-7000 ogatah@med.showa-u.ac.jp
Japan
 
NCT01578200
TRIGU1111, UMIN000006815
Not Provided
Translational Research Informatics Center, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
Showa University School of Medicine
Principal Investigator: Tadao Akizawa, MD, PhD Showa University
Translational Research Informatics Center, Kobe, Hyogo, Japan
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP