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

Primary Purpose

Hemodialysis, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Lanthanum Carbonate
Calcium Carbonate
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis focused on measuring CKD-MBD, phosphate-binder, vascular calcification, mortality, dialysis, Hemodialysis patients with hyperphosphatemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Showa University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lanthanum carbonate

Calcium Carbonate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cardiovascular event free survival time.
Cardiovascular event consisting of death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1), nonfatal myocardial infarction, nonfatal cerebral stroke including transient ischemic attack, TIA, unstable angina, hospitalization for heart failure, hospitalization for ventricular arrhythmia

Secondary Outcome Measures

Overall survival
Secondary hyperparathyroidism free survival
Hip fracture free survival
Quality of life questionnaire (KDQOL-SF, v1.3)
Bone mineral density (DEXA)

Full Information

First Posted
April 13, 2012
Last Updated
November 27, 2020
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Showa University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01578200
Brief Title
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study
Acronym
LANDMARK
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 24, 2011 (undefined)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Showa University School of Medicine

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Hyperphosphatemia
Keywords
CKD-MBD, phosphate-binder, vascular calcification, mortality, dialysis, Hemodialysis patients with hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanthanum carbonate
Arm Type
Experimental
Arm Description
Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.
Arm Title
Calcium Carbonate
Arm Type
Active Comparator
Arm Description
Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate
Primary Outcome Measure Information:
Title
Cardiovascular event free survival time.
Description
Cardiovascular event consisting of death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1), nonfatal myocardial infarction, nonfatal cerebral stroke including transient ischemic attack, TIA, unstable angina, hospitalization for heart failure, hospitalization for ventricular arrhythmia
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Secondary hyperparathyroidism free survival
Time Frame
3 years
Title
Hip fracture free survival
Time Frame
3 years
Title
Quality of life questionnaire (KDQOL-SF, v1.3)
Time Frame
3 years
Title
Bone mineral density (DEXA)
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadao Akizawa, MD, PhD
Organizational Affiliation
Showa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Showa University
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-0064
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34003226
Citation
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.
Results Reference
derived

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

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