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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01578200
Other study ID # TRIGU1111
Secondary ID UMIN000006815
Status Completed
Phase Phase 3
First received
Last updated
Start date December 24, 2011
Est. completion date March 25, 2019

Study information

Verified date March 2019
Source Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2309
Est. completion date March 25, 2019
Est. primary completion date March 25, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 ?-? - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lanthanum Carbonate

Calcium Carbonate


Locations

Country Name City State
Japan Showa University Shinagawa Tokyo

Sponsors (2)

Lead Sponsor Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan Showa University School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
3 years
Secondary Overall survival 3 years
Secondary Secondary hyperparathyroidism free survival 3 years
Secondary Hip fracture free survival 3 years
Secondary Quality of life questionnaire (KDQOL-SF, v1.3) 3 years
Secondary Bone mineral density (DEXA) 3 years
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