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A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Testing Paricalcitol for safety and effects in kids with advanced kidney disease.

Recruiting
9 years and younger
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study tests a medicine called paricalcitol for kids with a condition called Secondary Hyperparathyroidism (SHPT). SHPT can happen in children with serious kidney problems, like Stage 5 Chronic Kidney Disease (CKD), where kidneys aren't working well. The study is for kids aged 0 to 9 years who need special treatments like Peritoneal Dialysis (PD) or Hemodialysis (HD) to clean their blood. The study lasts 24 weeks and is split into two parts, each 12 weeks long.

To join, children must already have SHPT and be getting PD or HD for at least 30 days. They need to meet certain lab test requirements, based on age. Kids who are getting ready for a kidney transplant or who have had certain surgeries or medications recently can't join.

  • Study duration is 24 weeks, divided into two 12-week periods.
  • Participants must already be on dialysis for at least 30 days.
  • Some children, like those expecting a kidney transplant soon, cannot participate.
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Study details
    Chronic Kidney Disease (CKD)
    Secondary Hyperparathyroidism (SHPT)

NCT04064827

AbbVie

16 August 2025

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