deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01785849

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

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

Sponsor: Amgen

Conditions Hyperparathyroidism, Secondary
Interventions Etelcalcetide Placebo
Updated 13 times since 2017 Last updated: Aug 9, 2019 Started: Mar 12, 2013 Primary completion: May 22, 2014 Completion: Jun 12, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hyperparathyroidism, Secondary and is currently completed. Amgen leads this study, which shows 13 recorded versions since 2013 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2018 · 13 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~May 2019 · 7 months · monthly snapshot~May 2019 – ~Jul 2019 · 2 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Sep 2019 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 8 earlier versions

  1. Aug 2019 — Sep 2019 [monthly]

    Completed PHASE3

  2. Jul 2019 — Aug 2019 [monthly]

    Completed PHASE3

  3. May 2019 — Jul 2019 [monthly]

    Completed PHASE3

  4. Oct 2018 — May 2019 [monthly]

    Completed PHASE3

  5. Jun 2018 — Oct 2018 [monthly]

    Completed PHASE3

  6. May 2017 — Jun 2018 [monthly]

    Completed PHASE3

  7. Feb 2017 — May 2017 [monthly]

    Completed PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Mar 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalst, Belgium , Allentown, United States , Amherst, United States , Ashkelon, Israel , Austin, United States , Azusa, United States , Baja, Hungary , Barcelona, Spain , Baudour, Belgium , Berlin, Germany and 95 more locations