Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Condition(s) targeted: Hyperparathyroidism

Intervention: Placebo (Drug); AMG 073 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

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

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

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

To evaluate the safety of AMG 073 compared with placebo.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

AmgenTrials clinical trials website

Starting date: February 2002
Ending date: April 2003
Last updated: February 20, 2008