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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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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 / Treatment
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* Drug: cinacalcet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard of care, without use of cinacalcet. | Drug: cinacalcet<br>* Low dose vitamin D with cinacalcet<br>* Other names: cinacalcet + low dose vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving > 15% Progression of CAC. | Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52 | 52 weeks | 
| Absolute Change in PTH | Absolute change from baseline in intact Parathyroid Hormone (iPTH) | Baseline and Week 52 | 
| 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. | Baseline and Week 52 | 
| 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. | Baseline and Week 52 | 
| Percent Change in PTH | Percent change from baseline in intact Parathyroid Hormone (iPTH) | Baseline and Week 52 | 
| Absolute Change in Calcium | Absolute change from baseline in serum calcium to weeks 44 through 52 | Baseline and Weeks 44 through 52 | 
| Percent Change in Calcium | Percent change from baseline in corrected serum calcium to weeks 44 through 52 | Baseline and Weeks 44 through 52 | 
| Absolute Change in Phosphorus | Absolute change from baseline in serum phosphorus to weeks 44 through 52 | Baseline and Weeks 44 through 52 | 
| Percent Change in Phosphorus | Percent change from baseline in serum phosphorus to weeks 44 through 52 | Baseline and 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 | Baseline and Weeks 44 through 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 | Baseline and Weeks 44 through 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcification, vascular calcification, coronary vascular calcification, chronic kidney disease, end stage renal disease, dialysis