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NCT01785875 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Etelcalcetide 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
- 891
- Enrollment target
NCT01785875: Completed Phase 3 study, sponsored by Amgen.
NCT01785875 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 891 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01785875, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 891 participants
- Enrollment target
Study Summary
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
Primary Outcome
Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious eve
Interventions
- DRUG Etelcalcetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 891 participants |
| Start Date | 2013-07-31 |
| Est. Completion | 2015-07-01 |
| Phase | Phase 3 |
What the finished NCT01785875 record still lists
NCT01785875 is an interventional study that assigns participants to a tested intervention. The registered 891 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 1 intervention - of which Etelcalcetide is the first listed.
NCT01785875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01785875 about?
NCT01785875 is a clinical study titled "Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis". This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
What is the current status of trial NCT01785875?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 891 participants. The study started on 2013-07-31. Estimated completion is 2015-07-01.
What interventions are being tested in trial NCT01785875?
The interventions under investigation include: Etelcalcetide (DRUG).
Who is sponsoring clinical trial NCT01785875?
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 NCT01785875's enrollment target sits among peer trials
891 364th of 2000 higher than 1,637 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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