| Trial ID: | L1719 |
| Source ID: | NCT01578200
|
| Associated Drug: |
Lanthanum Carbonate
|
| Title: |
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study
|
| Acronym: |
LANDMARK
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hemodialysis|Hyperphosphatemia
|
| Interventions: |
DRUG: Lanthanum Carbonate|DRUG: Calcium Carbonate
|
| Outcome Measures: |
Primary: Cardiovascular event free survival time., 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, 3 years | Secondary: Overall survival, 3 years|Secondary hyperparathyroidism free survival, 3 years|Hip fracture free survival, 3 years|Quality of life questionnaire (KDQOL-SF, v1.3), 3 years|Bone mineral density (DEXA), 3 years
|
| Sponsor/Collaborators: |
Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Collaborators: Showa University School of Medicine
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2309
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-12-24
|
| Completion Date: |
2019-03-25
|
| Results First Posted: |
|
| Last Update Posted: |
2020-11-30
|
| Locations: |
Showa University, Shinagawa, Tokyo, 142-0064, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01578200
|
