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Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study (LANDMARK)
This study is ongoing, but not recruiting participants.
Sponsor:
Translational Research Informatics Center, Kobe, Hyogo, Japan
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: September 27, 2016
Last verified: September 2016
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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 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) |
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 ]
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 [ 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 ]
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01578200
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
| Responsible Party: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
| ClinicalTrials.gov Identifier: | NCT01578200 History of Changes |
| Other Study ID Numbers: |
TRIGU1111 UMIN000006815 ( Registry Identifier: UMIN Clinical Trials Registry ) |
| Study First Received: | April 13, 2012 |
| Last Updated: | September 27, 2016 |
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 Phosphorus Metabolism Disorders Metabolic Diseases Calcium, Dietary Calcium Carbonate |
Bone Density Conservation Agents Physiological Effects of Drugs Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on August 22, 2017