drugset / Trial / NCT04064827

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)

NCT04064827

Phase 3 Terminated 2 enrolled AbbVie
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2020-09-16
Primary completion
2025-06-09
Completion
2025-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Paricalcitol Other / unclassified 2.5 ug/ml Oral