Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00261950 | Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease | PHASE2 | COMPLETED | 110 | — | — | May 1, 2006 | May 1, 2011 | Jul 21, 2014 | 55 | United States, Belgium +10 |
| Arm | Type | Description |
|---|---|---|
| Cinacalcet | EXPERIMENTAL | All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm. |
| Name | Type | Description |
|---|---|---|
| Sensipar (Cinacalcet HCl) | DRUG | All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48. |
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria: * One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be \>/= 300 pg/mL. * One serum calcium determination obtained from the central laboratory must be \...