Double-Blind Study Comparing Doxercalciferol and Placebo in Vitamin D-Replete CKD Patients

作者：Patel Anita^*; Robertson John; Darwin Christine; Locay Harold; Anel Ramon; Engstrand Sara; Hunter John; Plone Melissa; Cangiano Jose

来源：Dialysis & Transplantation, 2011, 40(6): 252-257.

DOI：10.1002/dat.20583

OBJECTIVE: No well-controlled studies of the safety and efficacy of active vitamin D analogues have been conducted in vitamin D-replete (25-hydroxyvitamin D > 30 ng/mL) patients. This study assessed the safety and efficacy of doxercalciferol in vitamin D-replete patients with secondary hyperparathyroidism.
METHODS: This was a randomized, double-blind, placebo-controlled, parallel study. Twenty-four vitamin D-replete (exogenous ergocalciferol or intrinsically replete) patients with elevated intact parathyroid hormone (iPTH) were randomized to receive doxercalciferol or matching placebo capsules for 24 weeks. The dose was regularly titrated to achieve target iPTH levels (CKD Stage 3: <= 70 pg/mL; CKD Stage 4: <= 110 pg/mL).
RESULTS: Eleven (92%) doxercalciferol patients met the iPTH target range at least once post randomization compared with four (33%) placebo patients. All 12 (100%) doxercalciferol patients achieved a 30% reduction in iPTH at least once post randomization, and more doxercalciferol patients (83%) maintained iPTH within the target range for up to 6 weeks compared with the placebo patients (17%). Doxercalciferol and placebo were well tolerated during the study. No adverse events of hypercalcemia were reported.
CONCLUSIONS: Doxercalciferol was well tolerated and effective in reducing iPTH in vitamin D-replete CKD patients without accompanying hypercalcemia. Further studies in a larger population of vitamin D-replete patients are needed.

• 出版日期2011-6