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

NCT00379899 | Completed Phase 4 Results

• 1 other identifier: 20060111
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of Participants Achieving > 15% Progression of CAC.

  52 weeks

• Absolute Change in PTH

  Baseline and Week 52

• Change From Baseline in AC Score

  Baseline and Week 52

• Change From Baseline of the Progression of AVC.

  Baseline and Week 52

• Percent Change in PTH

  Baseline and Week 52

Study Arms (1)

Control

ACTIVE COMPARATOR

Standard of care, without use of cinacalcet.

Drug: cinacalcet

Interventions

cinacalcet DRUG

Low dose vitamin D with cinacalcet

Also known as: cinacalcet + low dose vitamin D

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (5)

• 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.

  PMID: 24151766 BACKGROUND

• 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.

  PMID: 22313328 BACKGROUND

• 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.

  PMID: 20110249 BACKGROUND

• 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.

  PMID: 21148030 BACKGROUND

• 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.

  PMID: 23028103 BACKGROUND

Related Links

• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Vascular Calcification; Calcinosis; Cardiovascular Diseases; Hyperparathyroidism; Kidney Diseases; Hyperparathyroidism, Secondary

Interventions

Cinacalcet; Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 25, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 23, 2014
• Results First Posted: October 27, 2010

Record last verified: 2014-07