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Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02102204
First Posted: April 2, 2014
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
Amgen
  Purpose
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Condition Intervention Phase
Hyperparathyroidism, Secondary Drug: Etelcalcetide Phase 3

Study Type: Interventional
Study Design: 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 Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days. ]

    A serious adverse event is an AE that met at least 1 of the following criteria:

    • fatal
    • life threatening
    • required in-patient hospitalization or prolongation of existing hospitalization
    • resulted in persistent or significant disability/incapacity
    • congenital anomaly/birth defect
    • other medically important serious event.

    The relationship of each AE to study treatment was assessed by the investigator.

    The following AE grading scale was used:

    Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.



Secondary Outcome Measures:
  • Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal [ Time Frame: Months 6, 12, and 18 ]
    The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.

  • Percentage of Participants With Serum Phosphorus ≤ the ULN [ Time Frame: Months 6, 12, and 18 ]
    Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.

  • Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL [ Time Frame: From day 1 to months 6, 12, and 18 ]

    The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.

    If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:

    cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made.


  • Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters [ Time Frame: Baseline to end of treatment; median duration of treatment was 563 days. ]
    The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.

  • Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies [ Time Frame: Baseline and every 6 months (up to 24 months) ]
    The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).


Enrollment: 902
Actual Study Start Date: March 25, 2014
Study Completion Date: June 26, 2017
Primary Completion Date: November 4, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etelcalcetide
Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
Drug: Etelcalcetide
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
Other Names:
  • KAI-4169
  • AMG 416
  • Parasabiv

Detailed Description:
This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
  • Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
  • Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
  • Subject has known sensitivity to any of the products or components to be administered during dosing
  • Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
  • Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
  • Subject is pregnant or nursing
  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): NCT02102204


  Show 229 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02102204     History of Changes
Other Study ID Numbers: 20130213
2013-004136-30 ( EudraCT Number )
KAI-4169 ( Other Identifier: KAI Pharmaceuticals (wholly owned subsidiary of Amgen, Inc.) )
First Submitted: March 3, 2014
First Posted: April 2, 2014
Results First Submitted: October 18, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis

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