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

Hemodialysis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578200
• Other study ID #: TRIGU1111
• Secondary ID: UMIN000006815
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Hemodialysis
• Hyperphosphatemia

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