Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00527267

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 III

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:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

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

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

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

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 February 09, 2012