Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide; Placebo
Intervention description: Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.; Administered intravenously (IV) three times per week.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 508.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject understands the study procedures and agrees to participate in the study by
             giving written informed consent.

          -  Subject is 18 years of age or older.

          -  Subject must be receiving hemodialysis 3 times weekly for at least 3 months

          -  Subject agrees to not participate in another study of an investigational agent during
             the study.

          -  Other Inclusion Criteria may apply

        Exclusion Criteria:

          -  Currently receiving treatment in another investigational device or drug study, or
             ended treatment on another investigational device or drug study(s) within 8 weeks
             prior to screening.

          -  Other investigational procedures while participating in this study are excluded.

          -  Anticipated or scheduled parathyroidectomy during the study period.

          -  Subject has received a parathyroidectomy within 3 months prior to dosing.

          -  Anticipated or scheduled kidney transplant during the study period.

          -  Subject has known sensitivity to any of the products or components to be administered
             during dosing.

          -  Subject has participated in a prior clinical trial of AMG 416 (also referred to as
             KAI-4169).

          -  Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment
             with cinacalcet is prohibited during the study).

          -  Subject has an unstable medical condition based on medical history, physical
             examination, and routine laboratory tests, or is otherwise unstable in the judgment of
             the Investigator.

          -  Other Exclusion Criteria may apply