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A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started2019-12-20
View on ClinicalTrials.gov ↗
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \< 18 years of age, with chronic kidney disease (CKD) on hemodialysis.

Amendment record

Amended 43 times since 2019-05-29; most recent filed 2026-08-20. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-20
Amendment Study Status v43
2026-03-19
Amendment Study Status, Contacts/Locations v42
2025-12-26
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v41
2025-10-15
Amendment Study Status, Contacts/Locations v40
2025-10-10
Amendment Study Status v39
2025-09-24
Amendment Study Status, Contacts/Locations v38
2025-09-03
Amendment Study Status v37
2025-08-13
Amendment Study Status, Contacts/Locations v36
2025-07-15
Amendment Study Status v35
2024-11-27
Amendment Study Status, Eligibility v34
2024-10-23
Amendment Study Status, Contacts/Locations v33
2024-09-18
Amendment Study Status, Contacts/Locations v32
2024-08-28
Amendment Study Status, Contacts/Locations v31
2024-08-08
Amendment Study Status, Contacts/Locations v30
2024-04-24
Amendment Study Status, Contacts/Locations v29
2024-03-27
Amendment Study Status, Contacts/Locations v28
2024-03-13
Amendment Study Status, Contacts/Locations v27
2023-11-29
Amendment Study Status, Contacts/Locations v26
2023-11-15
Amendment Study Status, Contacts/Locations v25
2023-11-08
Amendment Study Status, Contacts/Locations v24
2023-10-27
Amendment Study Status, Conditions, Outcome Measures v23
2023-09-13
Amendment Study Status, Contacts/Locations v22
2023-07-19
Amendment Study Status, Contacts/Locations v21
2023-07-05
Amendment Study Status, Contacts/Locations v20
2022-12-08
Amendment Study Status, Study Design, Eligibility, Contacts/Locations v19
2022-03-30
Amendment Study Status, Contacts/Locations v18
2022-03-10
Amendment Study Status v17
2022-03-02
Amendment Study Status, Contacts/Locations v16
2021-12-16
Amendment Study Identification, Study Status, Contacts/Locations, IPDSharing v15
2021-08-04
Amendment Study Status, Contacts/Locations v14
2021-06-03
Amendment Study Status, Contacts/Locations v13
2021-01-13
Amendment Study Status, Contacts/Locations v12
2020-12-07
Amendment Study Status, Eligibility, Contacts/Locations v11
2020-09-30
Amendment Study Status, Contacts/Locations v10
2020-04-16
Amendment Study Status, Eligibility v9
2020-03-18
Amendment Study Status, Contacts/Locations v8
2020-03-11
Amendment Study Status, Contacts/Locations v7
2020-02-19
Amendment Study Status, Contacts/Locations v6
2020-02-12
Amendment Study Status, Contacts/Locations v5
2020-01-22
Amendment Study Status, Contacts/Locations v4
2020-01-14
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
2019-12-03
Amendment Study Status, Study Description v2
2019-11-05
Amendment Study Identification, Study Status, Oversight, Study Description, Arms and Interventions v1
2019-05-29
Original filing
Trial Details
NCT Number NCT03969329
Lead Sponsor Amgen
Conditions Secondary Hyperparathyroidism
Enrollment 24 participants
Start Date 2019-12-20
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-21