| June 30, 2005 |
| November 19, 2009 |
| September 2004 |
| November 2005 (final data collection date for primary outcome measure) |
| Number of subjects with PTH less than or equal to 300pg/mL [ Time Frame: 21 week dose optimisation phase ] [ Designated as safety issue: No ] |
| Number of subjects with PTH less than or equal to 300pg/mL |
| Complete list of historical versions of study NCT00117052 on ClinicalTrials.gov Archive Site |
- Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes [ Time Frame: Dose Optimisation phase 21 weeks ] [ Designated as safety issue: No ]
- Safety of cinacalcet [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
|
- Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes
- Safety of cinacalcet
|
| |
| SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism |
| SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism |
The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study |
- Secondary Hyperparathyroidism
- End Stage Renal Disease
|
| Drug: cinacalcet |
- Active Comparator: Cinacalcet is given during the dialysis visit
- Active Comparator: Cinacalcet is administered with a post-dialysis meal
|
| Schaefer RM, Bover J, Dellanna F, Sanz D, Asensio C, Sánchez González MC, Gross P, Zani V, Carter D, Jehle PM. Efficacy of cinacalcet administered with the first meal after dialysis: the SENSOR Study. Clin Nephrol. 2008 Aug;70(2):126-34. |
| |
| Completed |
| 673 |
| February 2006 |
| November 2005 (final data collection date for primary outcome measure) |
Inclusion Criteria: - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL [2.1 mmol/L] Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets |
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Germany, Spain |
| |
| NCT00117052 |
| Global Development Leader, Amgen Inc. |
| 20040143 |
| Amgen |
|
|
|
| Amgen |
| November 2009 |
