drugset / Trial / NCT00110890
A Research Study for Patients With End-Stage Renal Disease (ESRD)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
Timeline
- Start
- 2004-05
- Primary completion
- 2005-04
- Completion
- 2007-09
Outcome
Met primary endpoint
registry Cinacalcet vs Standard of Care; p <0.001; Odds Ratio (OR) 8.74 (95% CI 5.72 to 13.36) NCT00110890 ↗
paper A higher proportion of patients receiving the cinacalcet-based regimen versus conventional care achieved the targets for PTH (71% versus 22%, respectively; P < 0.001) PMID 18178780 ↗
Publications
- Results Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008 Jan;3(1):36-45. doi: 10.2215/CJN.03591006.
- Results Wilkie M, Pontoriero G, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Zani VJ, Carter D, Messa P. Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet. Nephron Clin Pract. 2009;112(1):c41-50. doi: 10.1159/000212102. Epub 2009 Apr 10.
- Frazao JM, Braun J, Messa P, Dehmel B, Mattin C, Wilkie M. Is serum phosphorus control related to parathyroid hormone control in dialysis patients with secondary hyperparathyroidism? BMC Nephrol. 2012 Aug 3;13:76. doi: 10.1186/1471-2369-13-76.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cinacalcet | Other / unclassified | 30 mg | — |
| Subject | Cinacalcet | Other / unclassified | 60 mg | — |
| Subject | Cinacalcet | Other / unclassified | 90 mg | — |
| Subject | Cinacalcet | Other / unclassified | 120 mg | — |
| Subject | Cinacalcet | Other / unclassified | 180 mg | — |