Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006456

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006456
  •   2015/05/04
  •   2014/03/03
  •   no
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Secondary IDs

  •   2013-004136-30 
  •   NCT02102204  (ClinicalTrials.gov)
  •   20130213  (Amgen)
  •   2013-004136-30 
  •   KAI-4169 
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Health Condition or Problem studied

  •   Hyperparathyroidism, Secondary
  •   N25.8 -  Other disorders resulting from impaired renal tubular function
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Interventions/Observational Groups

  •   Drug: AMG 416
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
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  •   Single (group)
  •   III
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Primary Outcome

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

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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

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Israel
  •   Italy
  •   Latvia
  •   Lithuania
  •   Netherlands
  •   New Zealand
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Spain
  •   Sweden
  •   Switzerland
  •   Turkey
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Locations of Recruitment

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Recruitment

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  •   2014/03/31
  •   815
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   110   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Amgen
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    • Amgen
    • MD 
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    • Amgen
    • MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.