ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjec… (NCT00379899) | Clinical Trial Compass
CompletedPhase 4
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
360 participantsStarted 2006-09
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.