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Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01785875
Recruitment Status : Completed
First Posted : February 7, 2013
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 891 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
Study Start Date : July 2013
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Etelcalcetide
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Drug: Etelcalcetide
Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Other Name: AMG 416


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose until 30 days after last dose; the treatment period was 52 weeks. ]
    Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.

  2. Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 [ Time Frame: 52 weeks ]
    Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.

  3. Number of Participants Who Developed Anti-etelcalcetide Antibodies [ Time Frame: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit ]
    A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.

  4. Change From Baseline in Blood Pressure [ Time Frame: Baseline and Weeks 24 and 48 ]
    Blood pressure (BP) values were taken post-hemodialysis assessments.


Secondary Outcome Measures :
  1. Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase [ Time Frame: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment) ]
    The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.

  2. Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
    The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.

  3. Percentage of Participants With PTH ≤ 300 pg/mL During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  4. Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12 [ Time Frame: Week 46 to 53 ]
  5. Percent Change From Baseline in Mean PTH During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  6. Percent Change From Baseline in Mean PTH During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  7. Percent Change From Baseline in Mean Corrected Calcium During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  8. Percent Change From Baseline in Mean Corrected Calcium During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  9. Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  10. Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]
  11. Percent Change From Baseline in Mean Phosphorus During the EAP [ Time Frame: Baseline and the efficacy assessment phase ]
  12. Percent Change From Baseline in Mean Phosphorus During the EAP12 [ Time Frame: Baseline and the efficacy assessment phase at month 12 (weeks 46-53) ]

Eligibility Criteria

Information from the National Library of Medicine

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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 must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
  • 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.
  • Currently receiving other investigational procedures while participating in this study.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • 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

Contacts and Locations

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): NCT01785875


  Show 209 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01785875     History of Changes
Other Study ID Numbers: 20120231
KAI-4169-008 ( Other Identifier: KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.) )
2012-002808-41 ( EudraCT Number )
First Posted: February 7, 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