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NCT02859896 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT02859896: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT02859896 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02859896, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Primary Outcome
Blood samples were collected for assessment of iPTH levels. The percentage of participants meeting the iPTH \>=30% reduction from baseline at 2 consecutive study visits up to Week 12 was calculated. Two consecutive \>=30% reductions in iPTH from baseline up to Week 12 was defined as two consecutive 30% or greater reductions at any two consecutive measurements from baseline up to Week 12 with on-treatment strategy applied. The confidence interval (CI) was estimated using Clopper-Pearson method. T
Interventions
- DRUG Calcitriol
- DRUG Doxercalciferol (GZ427397)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2025-06-11 |
| Phase | Phase 3 |
Why NCT02859896 stopped before completion
NCT02859896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Calcitriol is the first listed.
NCT02859896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02859896 about?
NCT02859896 is a clinical study titled "Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis". Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihy...
What is the current status of trial NCT02859896?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2017-01-19. Estimated completion is 2025-06-11.
What interventions are being tested in trial NCT02859896?
The interventions under investigation include: Calcitriol (DRUG), Doxercalciferol (GZ427397) (DRUG).
Who is sponsoring clinical trial NCT02859896?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02859896's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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