| Title | Intravenous paricalcitol for treatment of secondary hyperparathyroidism in children on hemodialysis. | | Author(s) | Greenbaum LA, Benador N, Goldstein SL, Paredes A, Melnick JZ, Mattingly S, Amdahl M, Williams LA, Salusky IB | | Institution | Emory University and Children's Healthcare of Atlanta, GA 30322, USA. larry_greenbaum@oz.ped.emory.edu | | Source | Am J Kidney Dis 2007 Jun; 49(6):814-23. | | MeSH | Adolescent
Adult
Bone Density Conservation Agents
Calcium
Child
Child, Preschool
Double-Blind Method
Ergocalciferols
Female
Humans
Hyperparathyroidism
Infusions, Intravenous
Kidney Failure, Chronic
Male
Parathyroid Hormone
Phosphorus
Renal Dialysis
| | Abstract | 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.
STUDY DESIGN: Double blind, placebo-controlled. SETTING &
PARTICIPANTS: Hemodialysis units and pediatric subjects receiving hemodialysis.
INTERVENTION: 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)). OUTCOMES &
MEASUREMENTS: 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.
LIMITATIONS: Low power to detect differences in safety between groups and a short-term study.
CONCLUSION: 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. | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 17533024 |
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