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12-month Study of AMG 073 in Renal Osteodystrophy

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ClinicalTrials.gov Identifier: NCT00527085
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : May 8, 2013
Sponsor:
Information provided by:
Amgen

Brief Summary:
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 or disease Intervention/treatment Phase
Renal Osteodystrophy Drug: AMG 073 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2001
Primary Completion Date : August 2003
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry [ Time Frame: entire study ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the feasibility of measuring physical activity with accelerometry [ Time Frame: entire study ]
  3. To evaluate the safety and tolerability of AMG 073 compared with placebo [ Time Frame: entire study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527085


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00527085     History of Changes
Other Study ID Numbers: 20010141
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Chronic Kidney Disease-Mineral and Bone Disorder
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs