Hyperparathyroidism Secondary to Chronic Renal Disease
Doxercalciferol is used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) undergoing dialysis. Oral doxercalciferol also is used for the treatment of secondary hyperparathyroidism in patients with chronic renal disease (stage 3 and 4) who do not yet require maintenance dialysis (predialysis patients).
Results of randomized clinical trials in patients with chronic kidney disease (stage 5) undergoing dialysis indicate that oral or IV doxercalciferol is more effective than placebo in decreasing plasma intact parathyroid hormone (iPTH) concentrations, with substantially more patients achieving and maintaining target plasma iPTH concentrations while receiving doxercalciferol. Approximately 54% of patients receiving oral doxercalciferol achieved plasma iPTH concentrations within the target range (150-300 pg/mL) during weeks 14-16 (reduction in iPTH was maintained until the end of the study at 24 weeks) while about 53% of those receiving IV doxercalciferol achieved plasma iPTH concentrations within the target range during weeks 10-12 (study duration was 12 weeks). Limited data indicate that doxercalciferol-induced suppression of PTH may be associated with only a modest tendency to hypercalcemia.
Results of studies in patients with chronic kidney disease (stage 3 and 4) who do not yet require maintenance dialysis (predialysis patients) indicate that treatment with oral doxercalciferol is associated with substantially greater average decreases from baseline in plasma iPTH concentrations (101.4 pg/mL) than treatment with placebo (4.4 pg/mL). In these studies, mean plasma iPTH concentrations decreased by at least 30% from baseline for the last 4 weeks of therapy in 74 or 7% of patients receiving doxercalciferol or placebo, respectively.
For additional information on the use of vitamin D analogs, see the