Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Amgen

Status and phase: Completed; Phase 3

Conditions: Hyperparathyroidism

Treatments: Drug: Placebo; Drug: AMG 073

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527267

20000183

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

320 participants in 2 patient groups, including a placebo group

AMG 073

Experimental group

Description:

AMG 073

Treatment:

Drug: AMG 073

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo