Phase 4
N=360
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Chronic Kidney Disease · End Stage Renal Disease · Coronary Artery Calcification · Vascular Calcification · Calcification
Bottom Line
View on ClinicalTrials.gov: NCT00379899 ↗Enrolled (actual)
360
Serious AEs
47.2%
Results posted
Oct 2010
Primary outcome: Primary: Percent Change From Baseline in CAC Score — 43.74; 57.39 Units on a scale — p=0.073
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- cinacalcet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in CAC Score |
43.74; 57.39 | 0.073 |
| SECONDARY Number of Participants Achieving > 15% Progression of CAC. |
63; 77 | 0.094 |
| SECONDARY Absolute Change in PTH |
-132.86; -71.55 | 0.018 sig |
| SECONDARY Change From Baseline in AC Score |
935.92; 1677.28 | — |
| SECONDARY Change From Baseline of the Progression of AVC. |
24.29; 55.96 | 0.258 |
| SECONDARY Percent Change in PTH |
-18.18; -3.88 | 0.011 sig |
| SECONDARY Absolute Change in Calcium |
-0.51; 0.17 | <0.001 sig |
| SECONDARY Percent Change in Calcium |
-5.24; 1.98 | <0.001 sig |
| SECONDARY Absolute Change in Phosphorus |
-0.92; -0.24 | 0.025 sig |
| SECONDARY Percent Change in Phosphorus |
-9.63; 5.26 | 0.021 sig |
| SECONDARY Absolute Change in Ca x P |
-11.22; -1.32 | <0.001 sig |
| SECONDARY Percent Change in Ca x P |
-14.56; 6.54 | <0.001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00379899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.