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NCT01277510 · ClinicalTrials.gov registry record · Phase 3
Pediatric Chronic Kidney Disease Safety and Efficacy
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT01277510: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT01277510 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 43 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277510, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
Primary Outcome
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Interventions
- DRUG placebo
- DRUG Standard of Care
- DRUG cinacalcet capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-06-28 |
| Phase | Phase 3 |
Why NCT01277510 stopped before completion
NCT01277510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01277510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01277510 about?
NCT01277510 is a clinical study titled "Pediatric Chronic Kidney Disease Safety and Efficacy". The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
What is the current status of trial NCT01277510?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2011-06-28.
What interventions are being tested in trial NCT01277510?
The interventions under investigation include: placebo (DRUG), Standard of Care (DRUG), cinacalcet capsule (DRUG).
Who is sponsoring clinical trial NCT01277510?
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 NCT01277510's enrollment target sits among peer trials
43 1876th of 2000 higher than 124 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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