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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02102204
First received: March 3, 2014
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Hyperparathyroidism, Secondary
Drug: AMG 416
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Measure the subject incidence of adverse events reported [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 815
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)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102204

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 109 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02102204     History of Changes
Other Study ID Numbers: 20130213, 2013-004136-30, KAI-4169
Study First Received: March 3, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplasm Metastasis
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014