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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379899
• Other study ID #: 20060111
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2006
• Last updated: July 14, 2014
• Start date: September 2006
• Est. completion date: November 2009

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationEuropean Union: European Medicines AgencyUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcification
• Calcinosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Chronic Renal Failure
• Coronary Artery Calcification
• Coronary Artery Disease
• End Stage Renal Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Nephrology
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism
• Vascular Calcification

Intervention

Drug:
• cinacalcet
Low dose vitamin D with cinacalcet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (5)

Bellasi A, Reiner M, Pétavy 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. — View 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. — View 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. — View 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. — View Citation

Ureña-Torres PA, Floege J, Hawley CM, Pedagogos E, Goodman WG, Pétavy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants Achieving > 15% Progression of CAC.	Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52	52 weeks	No
Secondary	Absolute Change in PTH	Absolute change from baseline in intact Parathyroid Hormone (iPTH)	Baseline and Week 52	No
Secondary	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	No
Secondary	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	No
Secondary	Percent Change in PTH	Percent change from baseline in intact Parathyroid Hormone (iPTH)	Baseline and Week 52	No
Secondary	Absolute Change in Calcium	Absolute change from baseline in serum calcium to weeks 44 through 52	Baseline and Weeks 44 through 52	No
Secondary	Percent Change in Calcium	Percent change from baseline in corrected serum calcium to weeks 44 through 52	Baseline and Weeks 44 through 52	No
Secondary	Absolute Change in Phosphorus	Absolute change from baseline in serum phosphorus to weeks 44 through 52	Baseline and Weeks 44 through 52	No
Secondary	Percent Change in Phosphorus	Percent change from baseline in serum phosphorus to weeks 44 through 52	Baseline and Weeks 44 through 52	No
Secondary	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	No
Secondary	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	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling