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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 21, 2006
First Posted Date  ICMJE September 25, 2006
Results First Submitted Date  ICMJE October 1, 2010
Results First Posted Date  ICMJE October 27, 2010
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
Change from baseline in coronary artery calcification score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2010)
  • 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
  • Absolute Change in PTH [ Time Frame: Baseline and Week 52 ]
    Absolute change from baseline in intact Parathyroid Hormone (iPTH)
  • 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.
  • 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.
  • Percent Change in PTH [ Time Frame: Baseline and Week 52 ]
    Percent change from baseline in intact Parathyroid Hormone (iPTH)
  • Absolute Change in Calcium [ Time Frame: Baseline and Weeks 44 through 52 ]
    Absolute change from baseline in serum calcium to weeks 44 through 52
  • 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
  • Absolute Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ]
    Absolute change from baseline in serum phosphorus to weeks 44 through 52
  • Percent Change in Phosphorus [ Time Frame: Baseline and Weeks 44 through 52 ]
    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 ]
    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 ]
    Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
  • Change from baseline in coronary artery calcification score
  • Proportion of subjects achieving > 15% progression of coronary artery calcification.
  • Absolute and percent changes in PTH, calcium (Ca), phosphorus (P) and Ca x P.
  • Change from baseline of the progression of aortic valve calcification.
  • Safety and tolerability of cinacalcet.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • End Stage Renal Disease
  • Coronary Artery Calcification
  • Vascular Calcification
  • Calcification
  • Cardiovascular Disease
  • Chronic Renal Failure
  • Hyperparathyroidism
  • Kidney Disease
  • Nephrology
  • Secondary Hyperparathyroidism
Intervention  ICMJE Drug: cinacalcet
Low dose vitamin D with cinacalcet
Other Name: cinacalcet + low dose vitamin D
Study Arms  ICMJE Active Comparator: Control
Standard of care, without use of cinacalcet.
Intervention: Drug: cinacalcet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
360
Original Enrollment  ICMJE
 (submitted: September 21, 2006)
330
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Canada,   Finland,   France,   Germany,   Hungary,   Italy,   Poland,   Portugal,   Russian Federation,   Spain,   Switzerland,   United States
 
Administrative Information
NCT Number  ICMJE NCT00379899
Other Study ID Numbers  ICMJE 20060111
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP