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)
Phase 3
Terminated
NCT04064827
| Condition | Chronic Kidney Disease, Secondary Hyperparathyroidism |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | AbbVie |
|---|
| Status | Terminated |
|---|
| Enrollment | 2 participants |
|---|
| Interventions | Paricalcitol |
|---|
| Start date | Sep 16, 2020 |
|---|
| Completion date | Jun 9, 2025 |
|---|
| Results posted | Jun 15, 2026 |
|---|
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).
Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Up to Week 12 · percentage of participants
| Participants Receiving Paricalcitol | 100 percentage of participants |
|---|
Incidence of Hypercalcemia During Dosing Period 1
Up to Week 12 · Participants
| Participants Receiving Paricalcitol | 0 Participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.