Clinical Trial: To Assess the Long-term Safety of AMG 416 in the Treatment of SHPT in Subjects With CKD on Hemodialysis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Dise

Brief Summary: This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis.

Detailed Summary: This is a multicenter, single-arm, extension study in which subjects with secondary hyperparathyroidism currently receiving hemodialysis previously treated in AMG 20120231, 20120334, or 20120360 will continue to be treated with AMG 416. The study will assess the long-term safety and tolerability of AMG 416 as well as measuring the intact parathyroid hormone (iPTH), total serum albumin, corrected calcium (cCa), and serum phosphorous (P) values in these subjects during the course of their treatment.
Sponsor: Amgen

Current Primary Outcome: Measure the subject incidence of adverse events reported [ Time Frame: 2.5 Years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measure the occurrence of iPTH value [ Time Frame: months 6, 12, and 18 ]
    Within 2x to 9x the upper limit of normal for the assay used
  • Measure the occurrence of Serum phosphorous (P) [ Time Frame: months 6, 12, and 18 ]
    Less than or equal to the upper limit of normal for the assay used
  • Assess the nature, frequency, severity, and relationship to treatment of all adverse events reported [ Time Frame: 2.5 Years ]
  • Occurrence of cCa concentration < 7.5 mg/dL [ Time Frame: months 6, 12, and 18 ]
  • Assess vital signs, antibody formation to AMG 416, and changes in the laboratory parameters of albumin, total bilirubin (TBL), AST or ALT, and alkaline phosphatase [ Time Frame: 2.5 Years ]


Original Secondary Outcome:

  • Measure the occurrence of iPTH value [ Time Frame: months 6, 12, and 18 ]
    Within 2x to 9x the upper limit of normal for the assay used
  • Measure the occurrence of P ≤ 4.6 mg/dL [ Time Frame: months 6, 12, and 18 ]
  • Assess the nature, frequency, severity, and relationship to treatment of all adverse events reported [ Time Frame: 2.5 Years ]
  • Occurrence of cCa concentration < 7.5 mg/dL [ Time Frame: months 6, 12, and 18 ]
  • Assess vital signs, antibody formation to velcalcetide, and changes in the laboratory parameters of albumin, total bilirubin (TBL), AST or ALT, and alkaline phosphatase [ Time Frame: 2.5 Years ]


Information By: Amgen

Dates:
Date Received: March 3, 2014
Date Started: March 25, 2014
Date Completion: June 29, 2017
Last Updated: March 29, 2017
Last Verified: March 2017