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

Phase 3

Completed

• Conditions: Hemodialysis; Hyperphosphatemia
• Interventions: Drug: Lanthanum Carbonate; Drug: Calcium Carbonate

• Registration Number: NCT01578200
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Study Timeline

• Study Start: 2011-12-24
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Status Verified: 2019-03
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Last Update Submitted: 2020-11-27
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2309

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lanthanum carbonate	Lanthanum Carbonate	Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.
Calcium Carbonate	Calcium Carbonate	Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.

Primary Outcome Measures

Name	Time	Method
Cardiovascular event free survival time.	3 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Showa University; 🇯🇵 Shinagawa, Tokyo, Japan