ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00379899

Purpose

The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis

Condition	Intervention	Phase
Chronic Kidney Disease End Stage Renal Disease Coronary Artery Calcification Vascular Calcification Calcification Cardiovascular Disease Chronic Renal Failure Hyperparathyroidism Kidney Disease Nephrology Secondary Hyperparathyroidism	Drug: cinacalcet	Phase IV

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Cinacalcet Cinacalcet hydrochloride Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Study to Evaluate the Effects of Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease (CKD) Receiving Hemodialysis

Further study details as provided by Amgen:

Primary Outcome Measures:

Change from baseline in coronary artery calcification score [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving > 15% progression of coronary artery calcification. [ Time Frame: one year ] [ Designated as safety issue: No ]
Absolute and percent changes in PTH, calcium (Ca), phosphorus (P) and Ca x P. [ Time Frame: one year ] [ Designated as safety issue: No ]
Change from baseline of the progression of aortic valve calcification. [ Time Frame: one year ] [ Designated as safety issue: No ]
Safety and tolerability of cinacalcet. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Change from baseline in aortic calcification score [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	September 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Active Comparator Standard of care, without use of cinacalcet.	Drug: cinacalcet Low dose vitamin D with cinacalcet

Eligibility

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

Criteria

Inclusion Criteria:

Adults with chronic kidney disease receiving hemodialysis.
Lab tests required at screening include Parathyroid Hormone (PTH), calcium, and phosphorus.
A screening coronary artery calcification score of at least 30.

Exclusion Criteria:

Subjects on non-calcium or aluminum containing phosphate binders (example: sevelamer HCl, lanthanum) 30 days prior to screening.
Subjects on cinacalcet 30 days prior to screening.
Current or previous use of some osteoporosis medications.
Started or required change in cholesterol lowering medications within 30 days before screening.
Abnormal rhythm of the heart.
Parathyroidectomy done within 3 months prior to screening.
Anticipated parathyroidectomy or kidney transplant.
Current intolerance to oral medications, or inability to swallow.
Unstable medical condition.
Currently enrolled, or fewer than 30 days have passed since subject used another investigational device or drug.
Pregnancy or breast feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379899

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

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

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060111
Study First Received:	September 21, 2006
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00379899 History of Changes
Health Authority:	Australia: Therapeutic Goods Administration; European Union: European Medicines Agency; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Amgen:

calcification
vascular calcification
coronary vascular calcification

chronic kidney disease
end stage renal disease
dialysis

Study placed in the following topic categories:

Parathyroid Diseases
Renal Insufficiency
Myocardial Ischemia
Kidney Failure, Chronic
Bone Density Conservation Agents
Arteriosclerosis
Hyperparathyroidism, Secondary
Urologic Diseases
Vitamins
Neoplasm Metastasis
Micronutrients
Kidney Diseases
Metabolic Disorder
Arterial Occlusive Diseases

Metabolic Diseases
Heart Diseases
Vascular Diseases
Endocrine System Diseases
Trace Elements
Ischemia
Coronary Disease
Calcinosis
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Endocrinopathy
Coronary Artery Disease
Kidney Failure

Additional relevant MeSH terms:

Parathyroid Diseases
Renal Insufficiency
Myocardial Ischemia
Physiological Effects of Drugs
Kidney Failure, Chronic
Bone Density Conservation Agents
Arteriosclerosis
Calcium Metabolism Disorders
Hyperparathyroidism, Secondary
Urologic Diseases
Vitamins
Cardiovascular Diseases
Micronutrients
Kidney Diseases

Arterial Occlusive Diseases
Metabolic Diseases
Heart Diseases
Growth Substances
Vascular Diseases
Endocrine System Diseases
Pharmacologic Actions
Calcinosis
Coronary Disease
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Coronary Artery Disease
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009