12-month Study of AMG 073 in Renal Osteodystrophy - Full Text View

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:

Genetics Home Reference related topics: hereditary hypophosphatemic rickets

MedlinePlus related topics: Calcium

Drug Information available for: Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527085

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Malluche HH, Monier-Faugere MC, Wang G, Frazã O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. Clin Nephrol. 2008 Apr;69(4):269-78.

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 May 21, 2013