Intravenous paricalcitol for treatment of secondary hyperparathyroidism in children on hemodialysis

• Published in: American journal of kidney diseases Vol. 49; no. 6; p. 814
• Main Authors: Greenbaum, Larry A, Benador, Nadine, Goldstein, Stuart L, Paredes, Ana, Melnick, Joel Z, Mattingly, Susan, Amdahl, Michael, Williams, Laura A, Salusky, Isidro B
• Format: Journal Article
• Language: English
• Published: United States 01.06.2007
• Subjects: Adolescent; Adult; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - therapeutic use; Calcium - blood; Child; Child, Preschool; Double-Blind Method; Ergocalciferols - administration & dosage; Ergocalciferols - therapeutic use; Female; Humans; Hyperparathyroidism - blood; Hyperparathyroidism - drug therapy; Hyperparathyroidism - etiology; Infusions, Intravenous; Kidney Failure, Chronic - blood; Kidney Failure, Chronic - complications; Kidney Failure, Chronic - therapy; Male; Parathyroid Hormone - blood; Phosphorus - blood; Renal Dialysis
• ISSN: 1523-6838
• DOI: 10.1053/j.ajkd.2007.03.008

Secondary hyperparathyroidism is a common complication in children receiving hemodialysis. Active vitamin D is an effective therapy, but its use is often limited by hypercalcemia and increased calcium x phosphorus (Ca x P) product. Paricalcitol, a selective vitamin D receptor activator, causes less sustained hypercalcemia and increase in Ca x P product than calcitriol and has been used effectively in adult hemodialysis patients. Double blind, placebo-controlled. Hemodialysis units and pediatric subjects receiving hemodialysis. After a washout period of 2 to 6 weeks, 29 subjects aged 5 to 19 years received either paricalcitol or placebo for up to 12 weeks (0.04 mug/kg if initial intact parathyroid hormone [iPTH] level < 500 pg/mL [ng/L]; 0.08 mug/kg if initial iPTH level > 500 pg/mL [ng/L]). The dose was increased by 0.04 mug/kg every 2 weeks until there was a 30% decrease in iPTH level from baseline or calcium level greater than 11 mg/dL (>2.74 mmol/L) or Ca x P product greater than 75 mg(2)/dL(2) (>6.04 mmol(2)/L(2)). Two consecutive 30% decreases from baseline in iPTH levels and safety of paricalcitol, including hypercalcemia and increase in Ca x P product. 60% of the paricalcitol group had 2 consecutive 30% decreases from baseline iPTH levels compared with 21% in the placebo group (P = 0.06). The paricalcitol group had a mean decrease in iPTH level of 164 pg/mL (ng/L), whereas the placebo group had a mean increase of 238 pg/mL (ng/L; P = 0.03). There was no difference from baseline to final visit in calcium, phosphorus, or Ca x P product values in either group. Low power to detect differences in safety between groups and a short-term study. Paricalcitol decreased iPTH levels in children receiving hemodialysis with no significant changes in serum calcium, phosphorus, or Ca x P product values during the course of the study.