Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527267
• Other study ID #: 20000183
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2007
• Last updated: January 22, 2009
• Start date: February 2002
• Est. completion date: April 2003

Study information

• Verified date: January 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism

Intervention

Drug:
• Placebo
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
• AMG 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To evaluate the safety of AMG 073 compared with placebo.		Entire study - 26 weeks	Yes

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling