To Assess the Long-term Safety of AMG 416 in the Treatment of SHPT in Subjects With CKD on Hemodialysis
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|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 Disease on Hemodialysis|
- Measure the subject incidence of adverse events reported [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]
- Measure the occurrence of iPTH value [ Time Frame: months 6, 12, and 18 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- Occurrence of cCa concentration < 7.5 mg/dL [ Time Frame: months 6, 12, and 18 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: AMG 416
Investigational drug product is supplied as a sterile, preservative-free, aqueous solution for injection.
Drug: AMG 416
Subjects will be administered IV AMG 416 at the end of their regular dialysis sessions on a thrice weekly (TIW) schedule. Dose titration is at the discretion of the Investigator and will be based upon the values of the site's contracted laboratory provider iPTH and Ca (cCa, total Ca, or ionized Ca), with the frequency of these laboratory draws at the discretion of each individual Investigator, per standard of care for subjects receiving treatment with a calcimimetic agent. At a minimum however, calcium and albumin must be measured monthly. Subjects entering from the open-label parent studies 20120231 or 20120334 will receive a starting dose of AMG 416 identical to the last dose received in the parent study. Subjects entering from the randomized, double-blind parent Study 20120360, will receive a starting dose of 2.5 mg AMG 416. All subjects will continue to receive AMG 416 until approximately 2.5 years after the first subject enrolls.
Other Name: KAI-4169
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02102204
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