ADVANCE study provides new insights into the management of SHPT in CKD patients

March 13, 2017

Additional analyses presented at the ERA-EDTA 2010 Congress provide further support for the hypothesis that treatment with cinacalcet plus low doses of vitamin D may favourably affect the progression of calcification of cardiac valves compared to vitamin D alone(4) (Abstract Number: Sa116); highlight predictors of cardiovascular calcification in patients on dialysis(5) (Abstract Number: OSu039) and compare cardiovascular calcium scoring methods in the ADVANCE study(6) (Abstract Number: OM016).

ADVANCE Study Design

ADVANCE is a randomised, controlled trial to compare two treatment strategies for SHPT and their effects on the progression of CAC among patients on dialysis. ADVANCE studied 360 patients with SHPT and detectable CAC who were randomised to open label treatment with cinacalcet (30-180 mg/day) plus low-dose vitamin D (less than or equal to 2 ug IV paricalcitol equivalent/dialysis session) or to flexible vitamin D therapy. In both groups, calcium-based phosphate binders were used exclusively, and the therapeutic target for PTH was 150-300 pg/mL.

The primary endpoint for ADVANCE evaluated the percentage change in Agatston CAC score from baseline to week 52. Secondary endpoints for ADVANCE included:

Absolute change from baseline in CAC score at week 52Absolute and percentage change from baseline in aortic calcification score at week 52Absolute and percentage change from baseline in aortic and mitral valve calcification score at week 52Proportion of patients achieving > 15% progression of CAC at week 52Absolute and percentage changes in laboratory parameters (PTH, calcium, phosphorus)Safety and tolerability of cinacalcet