drugset / Trial / NCT01128179
Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD
RandomizedParallel-groupDouble-blindTreatment
Summary
To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.
Timeline
- Start
- 2010-12-06
- Primary completion
- 2012-04-16
- Completion
- 2012-04-16
Outcome
Missed primary endpoint
registry analysis (unspecified test); Lanthanum Carbonate vs Placebo; p = 0.3186; Mean Difference (Final Values) -0.1121 (95% CI -0.3389 to 0.1146); NCT01128179 ↗
paper No significant difference was seen in mean iFGF23 between groups at week 12. PMID 24885942 ↗
Publications
- Results Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lanthanum Carbonate | Other / unclassified | 1000 mg | — |