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Completed Phase 3 Interventional Results available

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

ClinicalTrials.gov ID: NCT01785849

Public ClinicalTrials.gov record NCT01785849. 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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:29 PM EDT

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 compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

Study identification

NCT ID
NCT01785849
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
508 participants

Conditions and interventions

Interventions

Drug

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
May 22, 2014 (Actual)
Completion
Jun 12, 2014 (Actual)
Last update posted
Aug 26, 2019

2013 – 2014

United States locations

U.S. sites
51
U.S. states
19
U.S. cities
47
Facility City State ZIP Site status
Research Site Birmingham Alabama 35211 —
Research Site Pine Bluff Arkansas 71603 —
Research Site Azusa California 91702 —
Research Site Covina California 91723 —
Research Site Lakewood California 90712 —
Research Site Los Angeles California 90025 —
Research Site Lynwood California 90262 —
Research Site Northridge California 91324 —
Research Site Ontario California 91762 —
Research Site Panorama City California 91402 —
Research Site Sacramento California 95825 —
Research Site Whittier California 90603 —
Research Site Pembroke Pines Florida 33028 —
Research Site Meridian Idaho 83642 —
Research Site Evanston Illinois 60201 —
Research Site Springfield Massachusetts 01107 —
Research Site Detroit Michigan 48236 —
Research Site Kalamazoo Michigan 49007 —
Research Site Pontiac Michigan 48341 —
Research Site Southgate Michigan 48195 —
Research Site Tupelo Mississippi 38801 —
Research Site Kansas City Missouri 64111 —
Research Site Reno Nevada 89511 —
Research Site Amherst New York 14226 —
Research Site Brooklyn New York 11235 —
Research Site Rosedale New York 11422 —
Research Site The Bronx New York 10461 —
Research Site Yonkers New York 10704 —
Research Site Chapel Hill North Carolina 27599 —
Research Site Durham North Carolina 27704 —
Research Site Allentown Pennsylvania 18104 —
Research Site Philadelphia Pennsylvania 19106 —
Research Site Philadelphia Pennsylvania 19118 —
Research Site Orangeburg South Carolina 29118 —
Research Site Sumter South Carolina 29150 —
Research Site Columbia Tennessee 38401 —
Research Site Nashville Tennessee 37205 —
Research Site Austin Texas 78758 —
Research Site Fort Worth Texas 76105 —
Research Site Fort Worth Texas 76164 —
Research Site Grand Prairie Texas 75050 —
Research Site Houston Texas 77030 —
Research Site Mansfield Texas 76063 —
Research Site San Antonio Texas 78205 —
Research Site San Antonio Texas 78215 —
Research Site San Antonio Texas 78229 —
Research Site Tyler Texas 75701 —
Research Site Fairfax Virginia 22033 —
Research Site Mechanicsville Virginia 23116 —
Research Site Norfolk Virginia 23502 —
Research Site Bluefield West Virginia 24701 —

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 67 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01785849, 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 26, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01785849 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →