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

Sponsor ID

20060111

Clinicaltrials.gov ID

NCT00379899

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

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

Additional Study Details

Phase

Phase 4

Product

cinacalcet hcl

Type

Interventional

Masking

None (Open Label)

Enrollment

360

Additional Study Details

Protocol Summary

Primary Outcome Measures

Percent Change from Baseline in CAC score

Timeframe: Baseline and Week 52

Secondary Outcome Measures

Number of Participants Achieving > 15% Progression of CAC.

Timeframe: 52 weeks

Absolute Change in PTH

Timeframe: Baseline and Week 52

Change from Baseline in AC score

Timeframe: Baseline and Week 52

Change from Baseline of the Progression of AVC.

Timeframe: Baseline and Week 52