Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)

Summary

Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4). Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study drug followed by a minimum of 12 weeks of open-label active drug.

Timeline

Start

2010-02

Primary completion

2014-05

Completion

2014-12

Outcome

Met primary endpoint

paper 27.8% of the paricalcitol group achieved two consecutive iPTH reductions of ≥30% from baseline versus none of the placebo group (P = 0.045). PMID 28332096 ↗

registry analysis (superiority or other test); Part 2: Placebo vs Part 2: Paricalcitol; p = 0.045; Difference 27.8 (95% CI 7.5 to 52.8); Fisher Exact NCT01020487 ↗

Publications

• Results Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paricalcitol	Other / unclassified	1 ug	Oral
Subject	Paricalcitol	Other / unclassified	3 ug	Oral

Indications