Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cinacalcet · 14 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 | - |
| 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...
Cinacalcet is a small molecule being developed for primary hyperparathyroidism, secondary hyperparathyroidism, chronic kidney disease, and chronic allograft nephropathy. It is an investigational drug in clinical development, not yet approved for these indications.
Cinacalcet is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hyperparathyroidism.
Cinacalcet is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for multiple indications including primary and secondary hyperparathyroidism and chronic kidney disease.
Cinacalcet has completed several clinical trials, including NCT00936650, NCT00936988, NCT03774771, and NCT03776058. These trials evaluated the drug in primary hyperparathyroidism, with a total enrollment of 181 patients across all studies.
Cinacalcet is a calcimimetic agent that targets the calcium-sensing receptor. By binding to this receptor, it increases sensitivity to extracellular calcium, thereby reducing parathyroid hormone secretion. This mechanism is relevant for treating hyperparathyroidism.
Yes, Cinacalcet is also known as AMG 073. Clinical trials such as NCT00936650 and NCT03774771 refer to the drug as AMG 073, confirming that these names refer to the same investigational compound.