drugset / Trial / NCT01069692
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
Timeline
- Start
- 2010-02
- Primary completion
- 2010-10
- Completion
- —
Outcome
Met primary endpoint
paper SBR759 showed significant reduction in serum phosphate levels compared with placebo at week 4, demonstrating a significant linear dose response (P < 0.001). PMID 23670305 ↗
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.
- Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SBR759A | Unknown | 3 g | Oral |
| Subject | SBR759A | Unknown | 6 g | Oral |
| Subject | SBR759A | Unknown | 9 g | Oral |
| Subject | SBR759A | Unknown | 12 g | Oral |