Clinical trial NCT00379899: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percent Change From Baseline in CAC Score
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Number of Participants Achieving > 15% Progression of CAC.
timeFrame: 52 weeks
measure: Absolute Change in PTH
timeFrame: Baseline and Week 52
measure: Change From Baseline in AC Score
timeFrame: Baseline and Week 52
measure: Change From Baseline of the Progression of AVC.
timeFrame: Baseline and Week 52
measure: Percent Change in PTH
timeFrame: Baseline and Week 52
measure: Absolute Change in Calcium
timeFrame: Baseline and Weeks 44 through 52
measure: Percent Change in Calcium
timeFrame: Baseline and Weeks 44 through 52
measure: Absolute Change in Phosphorus
timeFrame: Baseline and Weeks 44 through 52
measure: Percent Change in Phosphorus
timeFrame: Baseline and Weeks 44 through 52
measure: Absolute Change in Ca x P
timeFrame: Baseline and Weeks 44 through 52
measure: Percent Change in Ca x P
timeFrame: Baseline and Weeks 44 through 52
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.