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 Cinacalcet, Sensipar®, Mimpara®
AMG 073 · 19 trials · 18 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 |
| AMG 073 | EXPERIMENTAL | AMG 073 |
| 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 | - |
| AMG 073 | DRUG | 30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally |
| 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 2 | PHASE3 | Etelcalcetide |
| OPKO Health, Inc. | OPK | 1 | PHASE2 | CTAP101 |
AMG 073 is an investigational small molecule being developed for secondary hyperparathyroidism, end stage renal disease, and renal osteodystrophy. It is studied in dialysis patients with secondary hyperparathyroidism and in patients with renal osteodystrophy. The drug is not approved and remains in clinical development.
AMG 073 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug for conditions related to kidney disease and parathyroid disorders.
AMG 073 is in Phase 2 clinical development. It has completed Phase 2 and Phase 3 trials, but it remains investigational and is not approved by regulatory authorities. The drug is being studied for secondary hyperparathyroidism, end stage renal disease, and renal osteodystrophy.
AMG 073 has been studied in several completed trials. NCT00037635 and NCT00042653 are Phase 3 trials in dialysis patients with secondary hyperparathyroidism and end stage renal disease. NCT00110929 is a Phase 2 trial in end stage renal disease. NCT00527085 is a Phase 2 trial in renal osteodystrophy.
AMG 073 is the investigational code name for cinacalcet, a calcimimetic agent. It is being developed by Amgen for secondary hyperparathyroidism in patients with end stage renal disease on dialysis, as well as for renal osteodystrophy.