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Completed

NCT Number: NCT00527267

Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

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.

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Key information

Conditions

Hyperparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

    Time frame: Efficacy Assessment Phase - last 14 weeks of study

Secondary outcomes

  1. 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

    Time frame: Efficacy Assessment Phase - last 14 weeks of study

  2. 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

    Time frame: Efficacy Assessment Phase - last 14 weeks of study

  3. 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

    Time frame: Efficacy Assessment Phase - last 14 weeks of study

  4. To evaluate the safety of AMG 073 compared with placebo.

    Time frame: Entire study - 26 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Sep 10, 2007
Registry last updated
Jan 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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