Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). FDA label
Also known as Sensipar (Cinacalcet HCl), Cinacalcet, Mimpara
Sensipar · 15 trials · 17 indications
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
| Arm | Type | Description |
|---|---|---|
| Cinacalcet | EXPERIMENTAL | Participants received cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received \> 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. |
| During dialysis visit | ACTIVE_COMPARATOR | Cinacalcet is given during the dialysis visit |
| Post-dialysis meal | ACTIVE_COMPARATOR | Cinacalcet is administered with a post-dialysis meal |
| cinacalcet (AMG 073) | EXPERIMENTAL | - |
| Cinacalcet 50 mg QD | EXPERIMENTAL | In Part 1 participants received 50 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 30 mg cinacalcet capsules twice a day for 15 days. |
| Cinacalcet 75 mg QD | EXPERIMENTAL | In Part 1 participants received 75 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 40 mg cinacalcet capsules twice a day for 15 days. |
| Cinacelcet 100 mg QD | EXPERIMENTAL | In Part 1 participants received 100 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 50 mg cinacalcet capsules twice a day for 15 days. |
| Name | Type | Description |
|---|---|---|
| Cinacalcet | DRUG | Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg. |
| Placebo | DRUG | Administered orally following the same tiitration regimen as the experimental arm. |
| Cinacalcet HCl | DRUG | - |
| 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. |
| cinacalcet (AMG 073) | DRUG | Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks. |
INCLUSION CRITERIA: All subjects: * Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activ...
Sensipar is used for secondary hyperparathyroidism, a condition in which the parathyroid glands produce excess parathyroid hormone, often in patients with end stage renal disease. It is studied in dialysis patients with this condition. Sensipar is a small molecule therapy developed by Amgen Inc. for this endocrine indication.
Sensipar is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the company responsible for the clinical development of Sensipar for secondary hyperparathyroidism.
Sensipar is in Phase 2 clinical development for secondary hyperparathyroidism. The recorded trial is a completed Phase 2 study. Sensipar is investigational in this setting and is not described as approved for this use in the available development information.
Sensipar has been studied in one completed Phase 2 trial, NCT00261950, titled Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease. The trial enrolled 110 participants across the United States, Belgium, Czechia, Hungary, Italy, North Macedonia, Poland, Portugal, Spain, Switzerland, Turkey, and the United Kingdom.
Yes, Sensipar is also known as cinacalcet HCl. Sensipar (Cinacalcet HCl) is the same small molecule therapy developed by Amgen Inc. for secondary hyperparathyroidism. The two names refer to the same drug asset.