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Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

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ClinicalTrials.gov Identifier: NCT01785849
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : March 27, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

February 5, 2013
February 7, 2013
February 7, 2017
March 27, 2017
September 3, 2018
March 12, 2013
May 22, 2014   (Final data collection date for primary outcome measure)
Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). ]
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
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: one year ]
Complete list of historical versions of study NCT01785849 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
    Participants who had no scheduled assessments during the EAP were considered non-responders.
  • Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27) ]
  • Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
  • Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
  • Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
  • Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis cCa x P during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase [ Time Frame: one year ]
  • Number of subjects with adverse events [ Time Frame: one year ]
Not Provided
Not Provided
 
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
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
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hyperparathyroidism, Secondary
  • Drug: Etelcalcetide
    Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.
    Other Names:
    • AMG 416
    • KAI-4169
  • Drug: Placebo
    Administered intravenously (IV) three times per week.
  • Experimental: Etelcalcetide
    Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks.
    Intervention: Drug: Etelcalcetide
  • Placebo Comparator: Placebo
    Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
508
500
June 12, 2014
May 22, 2014   (Final data collection date for primary outcome measure)

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

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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Czech Republic
 
NCT01785849
20120229
KAI-4169-006 ( Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.) )
2012-002805-23 ( EudraCT Number )
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP