Overview

This trial is active, not recruiting.

Condition hyperparathyroidism, secondary
Treatment amg 416
Phase phase 3
Sponsor Amgen
Start date March 2014
End date June 2017
Trial size 902 participants
Trial identifier NCT02102204, 2013-004136-30, 20130213, KAI-4169

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Investigational drug product is supplied as a sterile, preservative-free, aqueous solution for injection.
amg 416 KAI-4169
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.

Primary Outcomes

Measure
Measure the subject incidence of adverse events reported
time frame: 2.5 Years

Secondary Outcomes

Measure
Measure the occurrence of iPTH value
time frame: months 6, 12, and 18
Measure the occurrence of Serum phosphorous (P)
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 AMG 416, and changes in the laboratory parameters of albumin, total bilirubin (TBL), AST or ALT, and alkaline phosphatase
time frame: 2.5 Years

Eligibility Criteria

Male or female participants from 18 years up to 110 years old.

Inclusion Criteria: - Subject has provided informed consent prior to initiation of any study-specific activities/procedures - Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01) - Female subjects who are: post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study - Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months Exclusion Criteria: - Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies) - Subject has known sensitivity to any of the products or components to be administered during dosing - Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study - Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L - Subject is pregnant or nursing

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Amgen.