Intravenous paricalcitol for treatment of secondary hyperparathyroidism in children on hemodialysis.
BACKGROUND
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.


METHODS
Double blind, placebo-controlled.


METHODS
Hemodialysis units and pediatric subjects receiving hemodialysis.


METHODS
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)).


METHODS
Two consecutive 30% decreases from baseline in iPTH levels and safety of paricalcitol, including hypercalcemia and increase in Ca x P product.


RESULTS
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.


CONCLUSIONS
Low power to detect differences in safety between groups and a short-term study.


CONCLUSIONS
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.
Greenbaum
Larry A
LA
Emory University and Children's Healthcare of Atlanta, GA 30322, USA. larry_greenbaum@oz.ped.emory.edu
Benador
Nadine
N
Goldstein
Stuart L
SL
Paredes
Ana
A
Melnick
Joel Z
JZ
Mattingly
Susan
S
Amdahl
Michael
M
Williams
Laura A
LA
Salusky
Isidro B
IB
D000293:Adolescent; D000328:Adult; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004872:Ergocalciferols / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006961:Hyperparathyroidism / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy; D008297:Male; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis
D050071:Bone Density Conservation Agents; D004872:Ergocalciferols; D010281:Parathyroid Hormone; D010758:Phosphorus; C084656:paricalcitol; D002118:Calcium