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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 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 21 participants.
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®.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02859896
The ClinicalTrials.gov registry entry for NCT02859896 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Calcitriol is the first listed.
NCT02859896 reports 0 study locations.
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.
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