Hyperparathyroidism
Conditions
Brief summary
Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.
Interventions
DRUGPlacebo
30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally
DRUGAMG 073
30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and Women greater than or equal to 18 years of age * Using effective contraceptive measures * Mean iPTH during screening of greater than or equal to 300 pg/mL * Mean calcium during screening of greater than or equal to 8.4 mg/dL * Stable on hemodialysis
Exclusion criteria
* Unstable medical conditions * Parathyroidectomy within 3 months * Change in Vitamin D therapy * Receiving antidepressants * Experienced an MI within 3 months * Inability to swallow tablets * Previously received AMG 073
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. | Efficacy Assessment Phase - last 14 weeks of study |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase | Efficacy Assessment Phase - last 14 weeks of study |
| To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase | Efficacy Assessment Phase - last 14 weeks of study |
| To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase | Efficacy Assessment Phase - last 14 weeks of study |
| To evaluate the safety of AMG 073 compared with placebo. | Entire study - 26 weeks |
Outcome results
None listed