Chronic Kidney DiseasePhase 4NCT00379899
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
A Phase 4 study testing cinacalcet in people with Chronic Kidney Disease and End Stage Renal Disease, run by Amgen.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification
- What is being tested?
- cinacalcet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
About this study
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
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
- Being tested
- cinacalcet
- Keywords
- calcification, vascular calcification, coronary vascular calcification, chronic kidney disease, end stage renal disease, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Vascular Calcification, Calcinosis, Cardiovascular Diseases, Hyperparathyroidism, Kidney Diseases, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcetDrug
Also called cinacalcet + low dose vitamin D
Low dose vitamin D with cinacalcet
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard of care, without use of cinacalcet. Receives: Drug: cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 52
Secondary outcomes (11)
Number of Participants Achieving > 15% Progression of CAC.
Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52
Measured: 52 weeks
Absolute Change in PTH
Absolute change from baseline in intact Parathyroid Hormone (iPTH)
Measured: 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.
Measured: 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.
Measured: Baseline and Week 52
Percent Change in PTH
Percent change from baseline in intact Parathyroid Hormone (iPTH)
Measured: Baseline and Week 52
Absolute Change in Calcium
Absolute change from baseline in serum calcium to weeks 44 through 52
Measured: Baseline and Weeks 44 through 52
Percent Change in Calcium
Percent change from baseline in corrected serum calcium to weeks 44 through 52
Measured: Baseline and Weeks 44 through 52
Absolute Change in Phosphorus
Absolute change from baseline in serum phosphorus to weeks 44 through 52
Measured: Baseline and Weeks 44 through 52
Percent Change in Phosphorus
Percent change from baseline in serum phosphorus to weeks 44 through 52
Measured: 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
Measured: 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
Measured: Baseline and Weeks 44 through 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379899
- Sponsor's protocol ID
- 20060111
- Status last verified
- Jul 2014
- First submitted
- 21 Sep 2006
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 24151766Boer 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.
PubMed 22313328Floege 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.
PubMed 20110249Raggi 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.
PubMed 21148030Urena-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.
PubMed 23028103
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00379899
- Acronym / sponsor ID
- 20060111
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification, Calcification, Cardiovascular Disease
- Keywords
- calcification, vascular calcification, coronary vascular calcification, chronic kidney disease, end stage renal disease, dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Posted 27 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: cinacalcetStandard of care, without use of cinacalcet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cinacalcetAlso: cinacalcet + low dose vitamin DLow dose vitamin D with cinacalcet | Drug | Control |
Primary outcome
Percent Change From Baseline in CAC Score
Time frame: Baseline and Week 52
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.
11 secondary outcomes
Number of Participants Achieving > 15% Progression of CAC.
Time frame: 52 weeks
Absolute Change in PTH
Time frame: Baseline and Week 52
Change From Baseline in AC Score
Time frame: Baseline and Week 52
Change From Baseline of the Progression of AVC.
Time frame: Baseline and Week 52
Percent Change in PTH
Time frame: Baseline and Week 52
Absolute Change in Calcium
Time frame: Baseline and Weeks 44 through 52
Percent Change in Calcium
Time frame: Baseline and Weeks 44 through 52
Absolute Change in Phosphorus
Time frame: Baseline and Weeks 44 through 52
Percent Change in Phosphorus
Time frame: Baseline and Weeks 44 through 52
Absolute Change in Ca x P
Time frame: Baseline and Weeks 44 through 52
Percent Change in Ca x P
Time frame: Baseline and Weeks 44 through 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24151766Bellasi 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.
- Background: PubMed 22313328Boer 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.
- Background: PubMed 20110249Floege 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.
- Background: PubMed 21148030Raggi 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.
- Background: PubMed 23028103Urena-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.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cinacalcet in people with Chronic Kidney Disease and End Stage Renal Disease, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in CAC Score (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379899, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.