drugset / Trial / NCT01231438
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.
RandomizedCrossoverOpen-labelTreatment
Summary
Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-03
- Completion
- 2011-03
Publications
- Results Bleskestad IH, Bergrem H, Hartmann A, Godang K, Goransson LG. Fibroblast growth factor 23 and parathyroid hormone after treatment with active vitamin D and sevelamer carbonate in patients with chronic kidney disease stage 3b, a randomized crossover trial. BMC Nephrol. 2012 Jun 28;13:49. doi: 10.1186/1471-2369-13-49.
- 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 | Alfacalcidol | Other / unclassified | 0.25 ug | — |
| Subject | sevelamer | Other / unclassified | 800 mg | — |