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

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv44
  2. Site details revised at 1 of 23 sitesv43
  3. Primary endpoint revised
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints revised (8)
    v42
  4. Site details revised at 1 of 23 sitesv41
  5. Re-verified, no change to tracked fieldsv40
Show 38 earlier versionsHide 38 earlier versions
  1. Site details revised at 1 of 23 sitesv39
  2. Re-verified, no change to tracked fieldsv38
  3. Study sites revised (23)v37
  4. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2027v36
  5. Eligibility criteria shortened, about 6 wordsv35
  6. Study sites: 22 to 23v34
  7. Study sites: 21 to 22v33
  8. Site details revised at 1 of 21 sitesv32
  9. Site details revised at 1 of 21 sitesv31
  10. Study sites revised (21)v30
  11. Site details revised at 1 of 21 sitesv29
  12. Site details revised at 1 of 21 sitesv28
  13. Study sites: 20 to 21v27
  14. Site details revised at 1 of 20 sitesv26
  15. Study sites revised (20)v25
  16. Secondary endpoints: 9 to 8v24
  17. Study sites revised (20)v23
  18. Site details revised at 1 of 20 sitesv22
  19. Study sites revised (20)v21
  20. Primary and study completion dates: Aug 2, 2026 to Jun 30, 2025
    • Enrollment target: 20 to 24
    • Study sites revised (20)
    • Eligibility criteria expanded, about 1 word
    v20
  21. Study sites: 19 to 20v19
  22. Primary and study completion dates: Jun 29, 2022 to Aug 2, 2026v18
  23. Site details revised at 3 of 19 sitesv17
  24. Study sites: 18 to 19
    • Study title expanded, about 2 words
    v16
  25. Site details revised at 1 of 18 sitesv15
  26. Study sites: 17 to 18v14
  27. Study sites: 16 to 17v13
  28. Study sites: 17 to 16
    • Eligibility criteria expanded, about 1 word
    v12
  29. Study sites: 15 to 17v11
  30. Eligibility criteria shortened, about 2 wordsv10
  31. Study sites: 14 to 15v9
  32. Study sites: 10 to 14v8
  33. Study sites: 9 to 10v7
  34. Study sites: 7 to 9v6
  35. Study sites: 6 to 7v5
  36. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Dec 23, 2019 to Dec 20, 2019
    v4
  37. Primary and study completion dates: Jun 30, 2022 to Jun 29, 2022
    • Start date: Dec 5, 2019 to Dec 23, 2019
    • Study description shortened, about 128 words
    v3
  38. Start date: Nov 4, 2019 to Dec 5, 2019
    • Study description expanded, about 128 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Amgen
170 trials monitored
See 10 trials at risk
Chronic Kidney Disease
1,428 trials monitored
See 74 trials at risk
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.
Trial Details
NCT Number NCT03969329
Lead Sponsor Amgen
Conditions
(from sponsor)		 Secondary Hyperparathyroidism
Related terms Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov