Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Public ClinicalTrials.gov record NCT01788046. 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 Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01788046
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 515 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 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
- Mar 12, 2013 (Actual)
- Primary completion
- Apr 14, 2014 (Actual)
- Completion
- May 9, 2014 (Actual)
- Last update posted
- Aug 20, 2019
2013 – 2014
United States locations
- U.S. sites
- 45
- U.S. states
- 25
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Mobile | Alabama | 36608 | — |
| Research Site | Azusa | California | 91702 | — |
| Research Site | Beverly Hills | California | 90211 | — |
| Research Site | Chula Vista | California | 91910 | — |
| Research Site | Fairfield | California | 94534 | — |
| Research Site | Glendale | California | 91205 | — |
| Research Site | Los Angeles | California | 90022 | — |
| Research Site | Northridge | California | 91324 | — |
| Research Site | Norwalk | California | 90650 | — |
| Research Site | Riverside | California | 92501 | — |
| Research Site | Simi Valley | California | 93065 | — |
| Research Site | Denver | Colorado | 80230 | — |
| Research Site | Stamford | Connecticut | 06902 | — |
| Research Site | Lauderdale Lakes | Florida | 33313 | — |
| Research Site | Miami | Florida | 33173 | — |
| Research Site | Ocala | Florida | 34471 | — |
| Research Site | Augusta | Georgia | 30901 | — |
| Research Site | Macon | Georgia | 31217 | — |
| Research Site | Chicago | Illinois | 60616 | — |
| Research Site | Gurnee | Illinois | 60031 | — |
| Research Site | Merrillville | Indiana | 46410 | — |
| Research Site | Wichita | Kansas | 67214-2998 | — |
| Research Site | Shreveport | Louisiana | 71101 | — |
| Research Site | Bethesda | Maryland | 20817 | — |
| Research Site | Ft. Washington | Maryland | 20744 | — |
| Research Site | Detroit | Michigan | 48202 | — |
| Research Site | Brookhaven | Mississippi | 39601 | — |
| Research Site | Lincoln | Nebraska | 68510 | — |
| Research Site | Las Vegas | Nevada | 89106 | — |
| Research Site | Eatontown | New Jersey | 07724 | — |
| Research Site | Brooklyn | New York | 11212 | — |
| Research Site | Fresh Meadows | New York | 11365 | — |
| Research Site | Great Neck | New York | 11021 | — |
| Research Site | Charlotte | North Carolina | 28207 | — |
| Research Site | New Bern | North Carolina | 28562 | — |
| Research Site | Cincinnati | Ohio | 45206 | — |
| Research Site | Columbia | South Carolina | 29203 | — |
| Research Site | Chattanooga | Tennessee | 37408 | — |
| Research Site | Knoxville | Tennessee | 37923 | — |
| Research Site | Arlington | Texas | 76015 | — |
| Research Site | Houston | Texas | 77054 | — |
| Research Site | Lubbock | Texas | 79430 | — |
| Research Site | Rutland | Vermont | 05701 | — |
| Research Site | Alexandria | Virginia | 22304 | — |
| Research Site | Morgantown | West Virginia | 26506-9165 | — |
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 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01788046, 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 Aug 20, 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 NCT01788046 live on ClinicalTrials.gov.