Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Amgen Identifier:
First received: March 3, 2014
Last updated: March 29, 2017
Last verified: March 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 902
Actual Study Start Date: March 25, 2014
Estimated Study Completion Date: June 29, 2017
Primary Completion Date: November 4, 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.

Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT02102204

  Show 229 Study Locations
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT02102204     History of Changes
Other Study ID Numbers: 20130213
2013-004136-30 ( EudraCT Number )
KAI-4169 ( Other Identifier: KAI Pharmaceuticals (wholly owned subsidiary of Amgen, Inc.) )
Study First Received: March 3, 2014
Last Updated: March 29, 2017

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism, Secondary
Neoplastic Processes
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases processed this record on April 26, 2017