NCT00527267CompletedPhase 3
A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 320
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
AMG 073
Experimental
AMG 073
Intervention: AMG 073 (Drug)
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: Efficacy Assessment Phase - last 14 weeks of study
Secondary Outcomes
- 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)
Investigators
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