Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006515

Trial Description

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Title

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and 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 study is designed to assess the efficacy and safety of AMG 416 compared with placebo in
the treatment of SHPT in CKD subjects receiving hemodialysis as assessed by the change from
baseline in serum iPTH, cCa x P and phosphorus.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006515
  •   2015/03/13
  •   2013/02/05
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2012-002805-23 
  •   NCT01785849  (ClinicalTrials.gov)
  •   20120229  (Amgen)
  •   KAI-4169-006 
  •   2012-002805-23 
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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
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Proportion of subjects with > 30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) which is defined as the period between Week 20 and Week 27.; time frame: 27 weeks

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Secondary Outcome

- Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase; time frame: 27 weeks
- Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase; time frame: 27 weeks
- Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase; time frame: 27 weeks
- Percent change from baseline in predialysis cCa x P during the Efficacy Assessment Phase; time frame: 27 weeks
- Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase; time frame: 27 weeks

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Israel
  •   Italy
  •   Poland
  •   Russian Federation
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2013/03/31
  •   508
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Subject understands the study procedures and agrees to participate in the study by
giving written informed consent.

- Subject is 18 years of age or older.

- Subject must be receiving hemodialysis 3 times weekly for at least 3 months

- Subject agrees to not participate in another study of an investigational agent during
the study.

- Other Inclusion Criteria may apply

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Exclusion Criteria

- Currently receiving treatment in another investigational device or drug study, or
ended treatment on another investigational device or drug study(s) within 8 weeks
prior to screening.

- Other investigational procedures while participating in this study are excluded.

- Anticipated or scheduled parathyroidectomy during the study period.

- Subject has received a parathyroidectomy within 3 months prior to dosing.

- Anticipated or scheduled kidney transplant during the study period.

- Subject has known sensitivity to any of the products or components to be administered
during dosing.

- Subject has participated in a prior clinical trial of AMG 416 (also referred to as
KAI-4169).

- Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment
with cinacalcet is prohibited during the study).

- Subject has an unstable medical condition based on medical history, physical
examination, and routine laboratory tests, or is otherwise unstable in the judgment
of the Investigator.

- Other Exclusion Criteria may apply

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Addresses

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    • Amgen
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    •   [---]*
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    • Amgen
    • MD 
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    •   [---]*
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    • Amgen
    • MD 
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    •   [---]*
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    •   [---]*
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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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    •   [---]*
    •   [---]*
    •   [---]*
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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 .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.