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NCT02138838 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT02138838: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT02138838 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02138838, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Primary Outcome
Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only.
Interventions
- DIETARY_SUPPLEMENT Standard of Care
- DRUG Cinacalcet HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2014-11-07 |
| Est. Completion | 2016-06-23 |
| Phase | Phase 3 |
Why NCT02138838 stopped before completion
NCT02138838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT02138838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02138838 about?
NCT02138838 is a clinical study titled "Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis". The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
What is the current status of trial NCT02138838?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2014-11-07. Estimated completion is 2016-06-23.
What interventions are being tested in trial NCT02138838?
The interventions under investigation include: Standard of Care (DIETARY_SUPPLEMENT), Cinacalcet HCl (DRUG).
Who is sponsoring clinical trial NCT02138838?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02138838's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 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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