Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) 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 weeks 5, 9, 13, and 17 (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: 515.0
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 (AMG 416) compared
      with placebo in the treatment of SHPT in CKD patients 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 agrees to not participate in another study of an investigational agent during
             the study.

          -  Subject must be receiving hemodialysis 3 times weekly for at least 3 months

          -  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

          -  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.

          -  Subject has a history of any illness that, in the opinion of the Investigator, might
             confound the results of the study or pose additional risk to the subject.

          -  Other Exclusion Criteria may apply