drugset / Trial / NCT01578200
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study
Phase 3
Completed
2309 enrolled
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Showa University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-12-24
- Primary completion
- 2019-03-25
- Completion
- 2019-03-25
Outcome
Missed primary endpoint
paper treatment of hyperphosphatemia with lanthanum carbonate compared with calcium carbonate did not result in a significant difference in composite cardiovascular events. PMID 34003226 ↗
Publications
- Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
- Ogata H, Fukagawa M, Hirakata H, Kagimura T, Fukushima M, Akizawa T; LANDMARK Investigators and Committees. Effect of Treating Hyperphosphatemia With Lanthanum Carbonate vs Calcium Carbonate on Cardiovascular Events in Patients With Chronic Kidney Disease Undergoing Hemodialysis: The LANDMARK Randomized Clinical Trial. JAMA. 2021 May 18;325(19):1946-1954. doi: 10.1001/jama.2021.4807.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Calcium carbonate | Other / unclassified | 3 g | Oral |
| Subject | Lanthanum Carbonate | Other / unclassified | 750 mg | Oral |
| Subject | Lanthanum Carbonate | Other / unclassified | 2250 mg | Oral |