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

• Status: Completed
• Trial end date: 2019-03-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborator: Showa University School of Medicine
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary

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