12-month Study of AMG 073 in Renal Osteodystrophy

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00527085
First received: September 6, 2007
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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

  Eligibility

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

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
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: NCT00527085

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

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

ClinicalTrials.gov processed this record on August 21, 2014