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

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ClinicalTrials.gov Identifier: NCT01788046
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Drug: Etelcalcetide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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 TIW for 26 weeks.
Drug: Etelcalcetide
Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (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 Name: AMG 416



Primary Outcome Measures :
  1. Percentage of Participants With > 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.


Secondary Outcome Measures :
  1. 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.

  2. 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) ]
  3. 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) ]
  4. Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase (Week 20 to Week 27) ]
  5. 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) ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 agrees to not participate in another study of an investigational agent during the study.
  • Subject must be receiving hemodialysis 3 times weekly for at least 3 months
  • 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
  • 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.
  • Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
  • Other Exclusion Criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788046


  Show 106 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01788046     History of Changes
Other Study ID Numbers: 20120230
KAI-4169-007 ( Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.) )
2012-002806-31 ( EudraCT Number )
First Posted: February 11, 2013    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: August 2016

Keywords provided by Amgen:
Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism

Additional relevant MeSH terms:
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases