Trial · NCT00379899
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
NCT00379899, Phase 4, Completed, Amgen; results first posted 2010-10-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis. Trials, record NCT00379899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00379899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
- NCT number
- NCT00379899
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 360 participants, actual
- Lead sponsor
- Amgen
- 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
- Interventions
- cinacalcet
- First posted
- 2006-09-25
- Last updated
- 2014-07-23
- Results first posted
- 2010-10-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in CAC Score | 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. |
| Secondary | Number of Participants Achieving > 15% Progression of CAC. | 52 weeks | Number of participants achieving \>15% progression of coronary artery calcification (CAC) at week 52 |
| Secondary | Absolute Change in PTH | Baseline and Week 52 | Absolute change from baseline in intact Parathyroid Hormone (iPTH) |
| Secondary | Change From Baseline in AC Score | Baseline and Week 52 | Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to \>75,000, with 0 representing no calcification. |
| Secondary | Change From Baseline of the Progression of AVC. | Baseline and Week 52 | Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to \>10,000, with 0 representing no calcification. |
| Secondary | Percent Change in PTH | Baseline and Week 52 | Percent change from baseline in intact Parathyroid Hormone (iPTH) |
| Secondary | Absolute Change in Calcium | Baseline and Weeks 44 through 52 | Absolute change from baseline in serum calcium to weeks 44 through 52 |
| Secondary | Percent Change in Calcium | Baseline and Weeks 44 through 52 | Percent change from baseline in corrected serum calcium to weeks 44 through 52 |
| Secondary | Absolute Change in Phosphorus | Baseline and Weeks 44 through 52 | Absolute change from baseline in serum phosphorus to weeks 44 through 52 |
| Secondary | Percent Change in Phosphorus | Baseline and Weeks 44 through 52 | Percent change from baseline in serum phosphorus to weeks 44 through 52 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in CAC Score | Baseline and Week 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Units on a scale | MEAN |
| SECONDARY | Number of Participants Achieving > 15% Progression of CAC. | 52 weeks | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Participants | NUMBER |
| SECONDARY | Absolute Change in PTH | Baseline and Week 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | pg/mL | MEAN |
| SECONDARY | Change From Baseline in AC Score | Baseline and Week 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Units on a scale | MEAN |
| SECONDARY | Change From Baseline of the Progression of AVC. | Baseline and Week 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Units on a scale | MEAN |
| SECONDARY | Percent Change in PTH | Baseline and Week 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Percentage | MEAN |
| SECONDARY | Absolute Change in Calcium | Baseline and Weeks 44 through 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | mg/dL | MEAN |
| SECONDARY | Percent Change in Calcium | Baseline and Weeks 44 through 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Percentage | MEAN |
| SECONDARY | Absolute Change in Phosphorus | Baseline and Weeks 44 through 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | mg/dL | MEAN |
| SECONDARY | Percent Change in Phosphorus | Baseline and Weeks 44 through 52 | Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score | Percentage | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in CAC Score | Cinacalcet | 43.74 | Standard Error 7.40 | Units on a scale | |
| Percent Change From Baseline in CAC Score | Control | 57.39 | Standard Error 7.77 | Units on a scale | |
| Number of Participants Achieving > 15% Progression of CAC. | Cinacalcet | 63 | Participants | ||
| Number of Participants Achieving > 15% Progression of CAC. | Control | 77 | Participants | ||
| Absolute Change in PTH | Cinacalcet | -132.86 | Standard Error 29.46 | pg/mL | |
| Absolute Change in PTH | Control | -71.55 | Standard Error 30.83 | pg/mL | |
| Change From Baseline in AC Score | Cinacalcet | 935.92 | Standard Error 233.81 | Units on a scale | |
| Change From Baseline in AC Score | Control | 1677.28 | Standard Error 385.39 | Units on a scale | |
| Change From Baseline of the Progression of AVC. | Cinacalcet | 24.29 | Standard Error 24.19 | Units on a scale | |
| Change From Baseline of the Progression of AVC. | Control | 55.96 | Standard Error 18.34 | Units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinacalcet | 180 | |
| Overall Study | STARTED | Control | 180 | |
| Overall Study | COMPLETED | Cinacalcet | 140 | |
| Overall Study | COMPLETED | Control | 140 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 40 | |
| Overall Study | NOT COMPLETED | Control | 40 |
Source ClinicalTrials.gov
Adverse events532
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cinacalcet | 6 | 180 | |
| other | Anaemia | Blood and lymphatic system disorders | Control Group | 13 | 180 | |
| other | Abdominal pain | Gastrointestinal disorders | Cinacalcet | 6 | 180 | |
| other | Abdominal pain | Gastrointestinal disorders | Control Group | 11 | 180 | |
| other | Diarrhoea | Gastrointestinal disorders | Cinacalcet | 29 | 180 | |
| other | Diarrhoea | Gastrointestinal disorders | Control Group | 22 | 180 | |
| other | Nausea | Gastrointestinal disorders | Cinacalcet | 29 | 180 | |
| other | Nausea | Gastrointestinal disorders | Control Group | 14 | 180 | |
| other | Vomiting | Gastrointestinal disorders | Cinacalcet | 23 | 180 | |
| other | Vomiting | Gastrointestinal disorders | Control Group | 22 | 180 |
1 to 10 of 532Source ClinicalTrials.gov
See all 532 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cinacalcet | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Cinacalcet | 95 | 180 |
| Total, other adverse events | Control Group | 93 | 180 |
| Total, serious adverse events | Cinacalcet | 88 | 180 |
| Total, serious adverse events | Control Group | 82 | 180 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cinacalcet vs Control: Number of Participants Achieving > 15% Progression of CAC. | Trial comparisons |
| Cinacalcet vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00379899
GET https://conductscience.org/api/trials/v1/NCT00379899/results?page=2