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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)

Evaluating paricalcitol's safety and effects in kids with advanced kidney disease.

Recruiting
9 years and younger
All
Phase 3
**Study Overview:** This research is about finding out how safe and effective a medicine called *paricalcitol* is for treating kids aged 0 to 9 with a condition called secondary hyperparathyroidism (SHPT), which is linked to severe kidney problems (stage 5 chronic kidney disease, or CKD). These kids receive special treatments called peritoneal dialysis (PD) or hemodialysis (HD) to help their kidneys. The study lasts for 24 weeks, broken into two parts, each lasting 12 weeks. **Key Points:** - **Commitment:** Participants will be involved for 24 weeks, with two 12-week dosing periods. - **Eligibility:** Must have SHPT, be on PD or HD for at least 30 days, and meet lab criteria. - **Restrictions:** No recent kidney transplant, certain medication use, or surgeries are allowed. This study is important because it could help children with severe kidney issues. However, joining requires several visits and strict eligibility criteria.
Study details
    Chronic Kidney Disease (CKD)
    Secondary Hyperparathyroidism (SHPT)

NCT04064827

AbbVie

11 May 2025

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