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NCT02102204 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
A Phase 3 study of Hyperparathyroidism, Secondary, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 902
- Enrollment target
- 20
- Study locations
NCT02102204: Completed Phase 3 study of Hyperparathyroidism, Secondary, sponsored by Amgen.
NCT02102204 is a Phase 3 study of Hyperparathyroidism, Secondary that has completed, run by Amgen. The registered enrollment target is 902 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02102204, a Phase 3 study of Hyperparathyroidism, Secondary, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 902 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
Primary Outcome
A serious adverse event is an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The relationship of each AE to study treatment was assessed by the investigator. The following AE grading scale was used: Mild: Transient or mild discomfort; no limitat
Conditions Studied
Interventions
- DRUG Etelcalcetide
Study Locations (20)
California
- Research Site - Alhambra
- Research Site - Azusa
- Research Site - Bakersfield
- Research Site - Cudahy
- Research Site - Granada Hills
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - Northridge
- Research Site - Riverside
- Research Site - Simi Valley
- Research Site - Vacaville
- Research Site - Whittier
Florida
- Research Site - Miami
- Research Site - Ocala
- Research Site - Pembroke Pines
- Research Site - Tampa
Colorado
- Research Site - Aurora
- Research Site - Westminster
Alabama
- Research Site - Birmingham
Connecticut
- Research Site - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 902 participants |
| Start Date | 2014-03-25 |
| Est. Completion | 2017-06-26 |
| Phase | Phase 3 |
What the finished NCT02102204 record still lists
NCT02102204 is an interventional study that assigns participants to a tested intervention. The registered 902 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 (17% higher).
The record links to 1 condition, with Hyperparathyroidism, Secondary appearing as the primary indexed condition, and to 1 intervention - of which Etelcalcetide is the first listed.
NCT02102204 names 20 study sites across 5 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT02102204 about?
NCT02102204 is a clinical study titled "Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis". This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
What is the current status of trial NCT02102204?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 902 participants. The study started on 2014-03-25. Estimated completion is 2017-06-26.
What conditions does trial NCT02102204 study?
This clinical trial studies the following conditions: Hyperparathyroidism, Secondary.
What interventions are being tested in trial NCT02102204?
The interventions under investigation include: Etelcalcetide (DRUG).
Who is sponsoring clinical trial NCT02102204?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02102204 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02102204's enrollment target sits among peer trials
902 349th of 2000 higher than 1,652 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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