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NCT01788046 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
NCT01788046: Completed Phase 3 study, sponsored by Amgen.
NCT01788046 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 515 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01788046, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
Study Summary
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
Primary Outcome
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
Interventions
- DRUG Placebo
- DRUG Etelcalcetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2013-03-12 |
| Est. Completion | 2014-05-09 |
| Phase | Phase 3 |
What the finished NCT01788046 record still lists
NCT01788046 is an interventional study that assigns participants to a tested intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01788046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01788046 about?
NCT01788046 is a clinical study titled "Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis". This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
What is the current status of trial NCT01788046?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2013-03-12. Estimated completion is 2014-05-09.
What interventions are being tested in trial NCT01788046?
The interventions under investigation include: Placebo (DRUG), Etelcalcetide (DRUG).
Who is sponsoring clinical trial NCT01788046?
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 NCT01788046's enrollment target sits among peer trials
515 724th of 2000 higher than 1,277 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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