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NCT04064827 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT04064827: Clinical Trial Phase 3 study, sponsored by AbbVie.
NCT04064827 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04064827, a Phase 3 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study 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).
Primary Outcome
Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Interventions
- DRUG Paricalcitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2025-06-09 |
| Phase | Phase 3 |
Why NCT04064827 stopped before completion
NCT04064827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Paricalcitol is the first listed.
NCT04064827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04064827 about?
NCT04064827 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT04064827?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2020-09-16. Estimated completion is 2025-06-09.
What interventions are being tested in trial NCT04064827?
The interventions under investigation include: Paricalcitol (DRUG).
Who is sponsoring clinical trial NCT04064827?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04064827's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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