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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

Primary Purpose

Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cinacalcet
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring calcification, vascular calcification, coronary vascular calcification, chronic kidney disease, end stage renal disease, dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    Control

    Arm Description

    Standard of care, without use of cinacalcet.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in CAC Score
    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.
    Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52
    Absolute Change in PTH
    Absolute change from baseline in intact Parathyroid Hormone (iPTH)
    Change From Baseline in AC Score
    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.
    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
    Percent change from baseline in intact Parathyroid Hormone (iPTH)
    Absolute Change in Calcium
    Absolute change from baseline in serum calcium to weeks 44 through 52
    Percent Change in Calcium
    Percent change from baseline in corrected serum calcium to weeks 44 through 52
    Absolute Change in Phosphorus
    Absolute change from baseline in serum phosphorus to weeks 44 through 52
    Percent Change in Phosphorus
    Percent change from baseline in serum phosphorus to weeks 44 through 52
    Absolute Change in Ca x P
    Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52
    Percent Change in Ca x P
    Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52

    Full Information

    First Posted
    September 21, 2006
    Last Updated
    July 14, 2014
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00379899
    Brief Title
    ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification, Calcification, Cardiovascular Disease, Chronic Renal Failure, Hyperparathyroidism, Kidney Disease, Nephrology, Secondary Hyperparathyroidism
    Keywords
    calcification, vascular calcification, coronary vascular calcification, chronic kidney disease, end stage renal disease, dialysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Standard of care, without use of cinacalcet.
    Intervention Type
    Drug
    Intervention Name(s)
    cinacalcet
    Other Intervention Name(s)
    cinacalcet + low dose vitamin D
    Intervention Description
    Low dose vitamin D with cinacalcet
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in CAC Score
    Description
    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.
    Time Frame
    Baseline and Week 52
    Secondary Outcome Measure Information:
    Title
    Number of Participants Achieving > 15% Progression of CAC.
    Description
    Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52
    Time Frame
    52 weeks
    Title
    Absolute Change in PTH
    Description
    Absolute change from baseline in intact Parathyroid Hormone (iPTH)
    Time Frame
    Baseline and Week 52
    Title
    Change From Baseline in AC Score
    Description
    Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.
    Time Frame
    Baseline and Week 52
    Title
    Change From Baseline of the Progression of AVC.
    Description
    Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.
    Time Frame
    Baseline and Week 52
    Title
    Percent Change in PTH
    Description
    Percent change from baseline in intact Parathyroid Hormone (iPTH)
    Time Frame
    Baseline and Week 52
    Title
    Absolute Change in Calcium
    Description
    Absolute change from baseline in serum calcium to weeks 44 through 52
    Time Frame
    Baseline and Weeks 44 through 52
    Title
    Percent Change in Calcium
    Description
    Percent change from baseline in corrected serum calcium to weeks 44 through 52
    Time Frame
    Baseline and Weeks 44 through 52
    Title
    Absolute Change in Phosphorus
    Description
    Absolute change from baseline in serum phosphorus to weeks 44 through 52
    Time Frame
    Baseline and Weeks 44 through 52
    Title
    Percent Change in Phosphorus
    Description
    Percent change from baseline in serum phosphorus to weeks 44 through 52
    Time Frame
    Baseline and Weeks 44 through 52
    Title
    Absolute Change in Ca x P
    Description
    Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52
    Time Frame
    Baseline and Weeks 44 through 52
    Title
    Percent Change in Ca x P
    Description
    Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52
    Time Frame
    Baseline and Weeks 44 through 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24151766
    Citation
    Bellasi A, Reiner M, Petavy F, Goodman W, Floege J, Raggi P. Presence of valvular calcification predicts the response to cinacalcet: data from the ADVANCE study. J Heart Valve Dis. 2013 May;22(3):391-9.
    Results Reference
    background
    PubMed Identifier
    22313328
    Citation
    Boer R, Lalla AM, Belozeroff V. Cost-effectiveness of cinacalcet in secondary hyperparathyroidism in the United States. J Med Econ. 2012;15(3):509-20. doi: 10.3111/13696998.2012.664799. Epub 2012 Feb 21.
    Results Reference
    background
    PubMed Identifier
    20110249
    Citation
    Floege J, Raggi P, Block GA, Torres PU, Csiky B, Naso A, Nossuli K, Moustafa M, Goodman WG, Lopez N, Downey G, Dehmel B, Chertow GM; ADVANCE Study group. Study design and subject baseline characteristics in the ADVANCE Study: effects of cinacalcet on vascular calcification in haemodialysis patients. Nephrol Dial Transplant. 2010 Jun;25(6):1916-23. doi: 10.1093/ndt/gfp762. Epub 2010 Jan 27.
    Results Reference
    background
    PubMed Identifier
    21148030
    Citation
    Raggi P, Chertow GM, Torres PU, Csiky B, Naso A, Nossuli K, Moustafa M, Goodman WG, Lopez N, Downey G, Dehmel B, Floege J; ADVANCE Study Group. The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. Nephrol Dial Transplant. 2011 Apr;26(4):1327-39. doi: 10.1093/ndt/gfq725. Epub 2010 Dec 8.
    Results Reference
    background
    PubMed Identifier
    23028103
    Citation
    Urena-Torres PA, Floege J, Hawley CM, Pedagogos E, Goodman WG, Petavy F, Reiner M, Raggi P. Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study. Nephrol Dial Transplant. 2013 Jan;28(1):146-52. doi: 10.1093/ndt/gfs356. Epub 2012 Sep 30.
    Results Reference
    background
    Links:
    URL
    http://www.sensipar.com/
    Description
    FDA-approved Drug Labeling
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    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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