Division of Nephrology, RWTH University of Aachen, Aachen, Germany.
Nephrol Dial Transplant. 2010 Jun;25(6):1916-23. doi: 10.1093/ndt/gfp762. Epub 2010 Jan 27.
The ADVANCE (A Randomized Study to Evaluate the Effects of Cinacalcet plus Low-Dose Vitamin D on Vascular Calcification in Subjects with Chronic Kidney Disease Receiving Haemodialysis) Study objective is to assess the effect of cinacalcet plus low-dose active vitamin D versus flexible dosing of active vitamin D on progression of coronary artery calcification (CAC) in haemodialysis patients. We report the ADVANCE Study design and baseline subject characteristics.
ADVANCE is a multinational, multicentre, randomized, open-label study. Adult haemodialysis patients with moderate to severe secondary hyperparathyroidism (intact parathyroid hormone [iPTH] >300 pg/mL or bio-intact PTH >160 pg/mL) and baseline CAC score >or=30 were stratified by CAC score (>or=30-399, >or=400-999, >or=1000) and randomized in a 1:1 ratio to cinacalcet (30-180 mg/day) plus low-dose active vitamin D (cinacalcet group) or flexible dosing of active vitamin D alone (control). The study had three phases: screening, 20-week dose titration and 32-week follow-up. CAC scores obtained by cardiac computed tomography were determined at screening and weeks 28 and 52. The primary end point was percentage change in CAC score from baseline to Week 52.
Subjects (n = 360) were randomized to cinacalcet or control. Mean age was 61.5 years, 43% were women, and median dialysis vintage was 36.7 months (range, 2.7-351.5 months). The baseline geometric mean CAC score by the Agatston method was 548.7 (95% confidence interval, 480.5-626.6). Baseline CAC score was independently associated with age, sex, dialysis vintage, diabetes and iPTH. Subjects also had extensive aortic and valvular calcification at baseline.
Subjects enrolled in ADVANCE have extensive CAC at baseline. The ADVANCE Study should help determine whether cinacalcet attenuates progression of vascular calcification.
ADVANCE（一项评估慢性肾脏病血液透析患者中西那卡塞联合低剂量活性维生素 D 对血管钙化进展的影响的随机研究）研究的目的是评估西那卡塞联合低剂量活性维生素 D 与活性维生素 D 灵活剂量对血液透析患者冠状动脉钙化（CAC）进展的影响。我们报告 ADVANCE 研究设计和基线患者特征。
ADVANCE 是一项多中心、多国、随机、开放标签研究。患有中重度继发性甲状旁腺功能亢进症（全段甲状旁腺激素 [iPTH] >300 pg/mL 或生物完整 PTH >160 pg/mL）且基线 CAC 评分≥30 的成年血液透析患者按 CAC 评分（≥30-399、≥400-999、≥1000）分层，并按 1:1 比例随机分为西那卡塞（30-180 mg/天）联合低剂量活性维生素 D（西那卡塞组）或单独活性维生素 D 灵活剂量（对照组）。该研究分为三个阶段：筛选期、20 周剂量滴定期和 32 周随访期。在筛选期和第 28 周和第 52 周时通过心脏计算机断层扫描（CT）获得 CAC 评分。主要终点是从基线到第 52 周时 CAC 评分的百分比变化。
360 名患者被随机分配至西那卡塞或对照组。平均年龄为 61.5 岁，43%为女性，中位透析龄为 36.7 个月（范围 2.7-351.5 个月）。Agatston 方法的基线几何平均 CAC 评分 548.7（95%置信区间 480.5-626.6）。基线 CAC 评分与年龄、性别、透析龄、糖尿病和 iPTH 独立相关。患者基线时还存在广泛的主动脉和瓣膜钙化。
ADVANCE 纳入的患者基线时 CAC 广泛存在。ADVANCE 研究应有助于确定西那卡塞是否能减缓血管钙化的进展。
