Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Public ClinicalTrials.gov record NCT01896232. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Study identification
- NCT ID
- NCT01896232
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 683 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2013 (Actual)
- Primary completion
- Nov 12, 2014 (Actual)
- Completion
- Jan 8, 2015 (Actual)
- Last update posted
- Jul 18, 2019
2013 – 2015
United States locations
- U.S. sites
- 41
- U.S. states
- 16
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Azusa | California | 91702 | — |
| Research Site | Bakersfield | California | 93306 | — |
| Research Site | Bakersfield | California | 93309 | — |
| Research Site | Chula Vista | California | 91910 | — |
| Research Site | Covina | California | 91723 | — |
| Research Site | Granada Hills | California | 91344 | — |
| Research Site | La Mesa | California | 91942 | — |
| Research Site | La Puente | California | 91744 | — |
| Research Site | Los Angeles | California | 90022 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | San Gabriel | California | 91776 | — |
| Research Site | Whittier | California | 90603 | — |
| Research Site | Arvada | Colorado | 80002 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Longmont | Colorado | 80501 | — |
| Research Site | Westminster | Colorado | 80031 | — |
| Research Site | Orange | Connecticut | 06477 | — |
| Research Site | Pembroke Pines | Florida | 33028 | — |
| Research Site | Pinecrest | Florida | 33156 | — |
| Research Site | Tampa | Florida | 33614 | — |
| Research Site | Baton Rouge | Louisiana | 70808 | — |
| Research Site | Lafayette | Louisiana | 70501 | — |
| Research Site | Southgate | Michigan | 48195 | — |
| Research Site | Columbus | Mississippi | 39705 | — |
| Research Site | Gulfport | Mississippi | 39501 | — |
| Research Site | Sewell | New Jersey | 08080 | — |
| Research Site | Great Neck | New York | 11021 | — |
| Research Site | Mineola | New York | 11501 | — |
| Research Site | Ridgewood | New York | 11385 | — |
| Research Site | Rosedale | New York | 11422 | — |
| Research Site | The Bronx | New York | 10461 | — |
| Research Site | Wilmington | North Carolina | 28401 | — |
| Research Site | Cincinnati | Ohio | 45206 | — |
| Research Site | Columbus | Ohio | 43215 | — |
| Research Site | Philadelphia | Pennsylvania | 19106 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Burlington | Vermont | 05401 | — |
| Research Site | Fairfax | Virginia | 22033 | — |
| Research Site | Portsmouth | Virginia | 23704 | — |
| Research Site | Madison | Wisconsin | 53713 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 141 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01896232, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2019 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01896232 live on ClinicalTrials.gov.