12-month Study of AMG 073 in Renal Osteodystrophy

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 6, 2007
Last updated: May 6, 2013
Last verified: May 2013

4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.

Condition Intervention Phase
Renal Osteodystrophy
Drug: AMG 073
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry [ Time Frame: entire study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • To evaluate the feasibility of measuring physical activity with accelerometry [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of AMG 073 compared with placebo [ Time Frame: entire study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: October 2001
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 073 Drug: AMG 073
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
Placebo Comparator: Placebo Drug: Placebo
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age of greater
  • Using effective contraceptive measures
  • iPTH greater than or equal to 300 pg/mL
  • Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
  • Stable hemodialysis for 1 month prior to day 1

Exclusion Criteria:

  • Any unstable medical condition
  • Pregnant or nursing women Recent parathyroidectomy
  • Change in Vitamin D therapy
  • Recent MI, Seizure, Malignancy, GI Disorder
  • Inability to swallow tablets
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527085

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00527085     History of Changes
Other Study ID Numbers: 20010141
Study First Received: September 6, 2007
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Renal Osteodystrophy
Parathyroid Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014