Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00527267
First received: September 6, 2007
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Hyperparathyroidism
Drug: Placebo
Drug: AMG 073
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the safety of AMG 073 compared with placebo. [ Time Frame: Entire study - 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: February 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 073
AMG 073
Drug: 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
Placebo Comparator: Placebo
Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527267

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00527267     History of Changes
Other Study ID Numbers: 20000183
Study First Received: September 6, 2007
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014