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Completed

NCT Number: NCT00379899

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

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

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Key information

Conditions

Chronic Kidney Disease Calcification Calcinosis Calcium Metabolism Disorders Cardiovascular Disease Cardiovascular Diseases Chronic Disease Chronic Renal Failure Coronary Artery Calcification Disease Attributes End Stage Renal Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Disease Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nephrology Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Secondary Hyperparathyroidism Urogenital Diseases Urologic Diseases Vascular Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinacalcet

Drug

Low dose vitamin D with cinacalcet

Other names: cinacalcet + low dose vitamin D

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2006
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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