Trials / Terminated
TerminatedNCT04064827
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)
A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 0 Years – 9 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paricalcitol | Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser |
Timeline
- Start date
- 2020-09-16
- Primary completion
- 2025-06-09
- Completion
- 2025-06-09
- First posted
- 2019-08-22
- Last updated
- 2025-12-04
Locations
15 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04064827. Inclusion in this directory is not an endorsement.