Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

NCT00527267 | Completed Phase 3

• 1 other identifier: 20000183
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

AMG 073

EXPERIMENTAL

AMG 073

Drug: AMG 073

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

AMG 073 DRUG

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

AMG 073

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hyperparathyroidism

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: February 1, 2002
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: January 26, 2009

Record last verified: 2009-01