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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00379899
First received: September 21, 2006
Last updated: July 14, 2014
Last verified: July 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percent Change From Baseline in CAC Score [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Achieving > 15% Progression of CAC. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52

  • Absolute Change in PTH [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Absolute change from baseline in intact Parathyroid Hormone (iPTH)

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

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

  • Percent Change in PTH [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Percent change from baseline in intact Parathyroid Hormone (iPTH)

  • Absolute Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ] [ Designated as safety issue: No ]
    Absolute change from baseline in serum calcium to weeks 44 through 52

  • Percent Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ] [ Designated as safety issue: No ]
    Percent change from baseline in corrected serum calcium to weeks 44 through 52

  • Absolute Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ] [ Designated as safety issue: No ]
    Absolute change from baseline in serum phosphorus to weeks 44 through 52

  • Percent Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ] [ Designated as safety issue: No ]
    Percent change from baseline in serum phosphorus to weeks 44 through 52

  • Absolute Change in Ca x P [ Time Frame: Baseline and Weeks 44 through 52 ] [ Designated as safety issue: No ]
    Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52

  • Percent Change in Ca x P [ Time Frame: Baseline and Weeks 44 through 52 ] [ Designated as safety issue: No ]
    Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52


Enrollment: 360
Study Start Date: September 2006
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00379899     History of Changes
Other Study ID Numbers: 20060111
Study First Received: September 21, 2006
Results First Received: October 1, 2010
Last Updated: July 14, 2014
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

Additional relevant MeSH terms:
Kidney Diseases
Calcinosis
Cardiovascular Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Renal Insufficiency
Vascular Calcification
Renal Insufficiency, Chronic
Coronary Artery Disease
Arteriosclerosis
Calcium Metabolism Disorders
Metabolic Diseases
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014