Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006502

Trial Description

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Title

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to demonstrate that treatment with AMG 416 is not inferior to
treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by
>30%.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006502
  •   2015/01/09
  •   2013/07/08
  •   no
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Secondary IDs

  •   NCT01896232  (ClinicalTrials.gov)
  •   20120360  (Amgen)
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Health Condition or Problem studied

  •   Secondary Hyperparathyroidism; Chronic Kidney Disease
  •   N25.8 -  Other disorders resulting from impaired renal tubular function
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Interventions/Observational Groups

  •   Drug: AMG 416
  •   Drug: cinacalcet
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Reduction in mean pre-dialysis serum PTH level; time frame: Weeks 20-27; Achievement of a > 30% reduction in mean pre-dialysis serum PTH level from baseline during the efficacy assessment phase (EAP) of the study

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Secondary Outcome

- Vomiting or nausea; time frame: in the first 8 weeks; Mean number of days of vomiting or nausea per week in the first 8 weeks
- Reduction in mean pre-dialysis serum PTH; time frame: ´╗┐Weeks 20-27; Achievement of a > 50% reduction from baseline in mean pre-dialysis serum PTH during the EAP
- Change in mean pre-dialysis serum cCa; time frame: Weeks 20-27; Percent change from baseline in mean pre-dialysis serum cCa during the EAP
- Pre-dialysis serum phosphorus; time frame: Weeks 20-27; Achievement of mean pre-dialysis serum P ≤ 4.5 mg/dL during the EAP
- Severity of nausea; time frame: in the first 8 weeks; Mean severity of nausea in the first 8 weeks
- Vomiting; time frame: in the first 8 weeks; Mean number of episodes of vomiting per week in the first 8 weeks

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Countries of Recruitment

  •   United States
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Estonia
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Latvia
  •   Lithuania
  •   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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  •   2013/08/31
  •   683
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

- Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis
with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to
screening laboratory assessments

- Subjects must have SHPT as defined by one central laboratory screening predialysis
serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to
randomization

- Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2
weeks of the date of randomization

- Subjects receiving calcium supplements must have no more than a maximum dose change
of 50% within 2 weeks before screening laboratory assessments are obtained, and the
dose must remain unchanged through randomization

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Exclusion Criteria

- Eligible subjects cannot have received cinacalcet during the 3 months preceding the
first screening laboratory assessment

- Other criteria may apply

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Addresses

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