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

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ClinicalTrials.gov Identifier: NCT00379899
Recruitment Status : Completed
First Posted : September 25, 2006
Results First Posted : October 27, 2010
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
Standard of care, without use of cinacalcet.
 Drug: cinacalcet
Low dose vitamin D with cinacalcet
Other Name: cinacalcet + low dose vitamin D


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in CAC Score [ Time Frame: Baseline and Week 52 ]
    Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.


Secondary Outcome Measures :
  1. Number of Participants Achieving > 15% Progression of CAC. [ Time Frame: 52 weeks ]
    Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52

  2. Absolute Change in PTH [ Time Frame: Baseline and Week 52 ]
    Absolute change from baseline in intact Parathyroid Hormone (iPTH)

  3. Change From Baseline in AC Score [ Time Frame: Baseline and Week 52 ]
    Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.

  4. Change From Baseline of the Progression of AVC. [ Time Frame: Baseline and Week 52 ]
    Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.

  5. Percent Change in PTH [ Time Frame: Baseline and Week 52 ]
    Percent change from baseline in intact Parathyroid Hormone (iPTH)

  6. Absolute Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ]
    Absolute change from baseline in serum calcium to weeks 44 through 52

  7. Percent Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ]
    Percent change from baseline in corrected serum calcium to weeks 44 through 52

  8. Absolute Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ]
    Absolute change from baseline in serum phosphorus to weeks 44 through 52

  9. Percent Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ]
    Percent change from baseline in serum phosphorus to weeks 44 through 52

  10. Absolute Change in Ca x P [ Time Frame: Baseline and Weeks 44 through 52 ]
    Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52

  11. Percent Change in Ca x P [ Time Frame: Baseline and Weeks 44 through 52 ]
    Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00379899


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

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00379899    
Other Study ID Numbers: 20060111
First Posted: September 25, 2006    Key Record Dates
Results First Posted: October 27, 2010
Last Update Posted: July 23, 2014
Last Verified: July 2014
Keywords provided by Amgen:
calcification
vascular calcification
coronary vascular calcification
 chronic kidney disease
end stage renal disease
dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Cardiovascular Diseases
Calcinosis
Vascular Calcification
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
 Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D
Cinacalcet
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists