drugset / Trial / NCT01181531
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.
Timeline
- Start
- 2010-10-01
- Primary completion
- 2012-07-17
- Completion
- 2012-08-14
Publications
- Background Wetmore JB, Gurevich K, Sprague S, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1031-40. doi: 10.2215/CJN.07050714. Epub 2015 Apr 22.
- Sprague SM, Wetmore JB, Gurevich K, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. Effect of Cinacalcet and Vitamin D Analogs on Fibroblast Growth Factor-23 during the Treatment of Secondary Hyperparathyroidism. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1021-30. doi: 10.2215/CJN.03270314. Epub 2015 Apr 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alfacalcidol | Other / unclassified | — | Oral |
| Comparator | Calcitriol | Small molecule | — | Oral |
| Subject | Cinacalcet | Other / unclassified | 180 mg | Oral |
| Comparator | Doxercalciferol | Small molecule | — | Oral |
| Comparator | Paricalcitol | Other / unclassified | — | Oral |