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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT02102204
Collaborator
(none)
902
Enrollment
229
Locations
1
Arm
39.1
Actual Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
902 participants
Allocation:
N/A
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
Actual Study Start Date :
Mar 25, 2014
Actual Primary Completion Date :
Nov 4, 2016
Actual Study Completion Date :
Jun 26, 2017

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events [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

    1. Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal [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.

    2. Percentage of Participants With Serum Phosphorus ≤ the ULN [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.

    3. Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL [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.

    4. Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters [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.

    5. Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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    213 Research Site Karlstad Sweden 651 85
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    218 Research Site Aarau Switzerland 5001
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    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT02102204
    Other Study ID Numbers:
    • 20130213
    • 2013-004136-30
    • KAI-4169
    First Posted:
    Apr 2, 2014
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Oct 1, 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:
    Neoplasm Metastasis
    Kidney Diseases
    Renal Insufficiency, Chronic
    Hyperparathyroidism
    Hyperparathyroidism, Secondary

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 229 study centers in Europe, Australia, New Zealand, and North America
    Pre-assignment Detail A total of 902 participants were enrolled in Study 20130213: 215 and 200 participants from the cinacalcet and etelcalcetide groups of the double-blind parent Study 20120360 (NCT01896232), respectively, and 487 participants from the open-label parent Studies 20120231 (NCT01785875) and 20120334 (NCT01576146).
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Period Title: Overall Study
    STARTED 902
    Received Etelcalcetide 884
    COMPLETED 598
    NOT COMPLETED 304

    Baseline Characteristics

    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Overall Participants 884
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.7
    (14.3)
    Age, Customized (Count of Participants)
    < 65 years
    582
    65.8%
    ≥ 65 years
    302
    34.2%
    Sex: Female, Male (Count of Participants)
    Female
    357
    40.4%
    Male
    527
    59.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    78
    8.8%
    Not Hispanic or Latino
    806
    91.2%
    Unknown or Not Reported
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    1
    0.1%
    Asian
    14
    1.6%
    Black
    192
    21.7%
    Native Hawaiian or Other Pacific Islander
    9
    1%
    White
    657
    74.3%
    Other
    11
    1.2%
    Parathyroid Hormone (pg/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pg/mL]
    528.3
    (566.4)
    Albumin Corrected Calcium (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    8.94
    (0.79)
    Phosphorus (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    5.24
    (1.69)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events
    Description 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.
    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.

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least 1 dose of etelcalcetide in the current study (20130213).
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Measure Participants 884
    Any adverse event
    768
    86.9%
    Serious adverse events
    436
    49.3%
    Treatment-related adverse events
    287
    32.5%
    Serious treatment-related adverse events
    4
    0.5%
    AEs leading to discontinuation of etelcalcetide
    41
    4.6%
    Fatal adverse events
    89
    10.1%
    Mild adverse events
    123
    13.9%
    Moderate adverse events
    219
    24.8%
    Severe adverse events
    324
    36.7%
    Life-threatening adverse events
    102
    11.5%
    2. Secondary Outcome
    Title Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
    Description 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.
    Time Frame Months 6, 12, and 18

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Measure Participants 884
    Month 6
    67.0
    7.6%
    Month 12
    73.2
    8.3%
    Month 18
    71.9
    8.1%
    3. Secondary Outcome
    Title Percentage of Participants With Serum Phosphorus ≤ the ULN
    Description Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
    Time Frame Months 6, 12, and 18

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Measure Participants 884
    Month 6
    39.4
    4.5%
    Month 12
    40.0
    4.5%
    Month 18
    36.8
    4.2%
    4. Secondary Outcome
    Title Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
    Description 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.
    Time Frame From day 1 to months 6, 12, and 18

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at the beginning of the time interval.
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Measure Participants 871
    Day 1 to Month 6
    9.5
    1.1%
    Day 1 to Month 12
    14.1
    1.6%
    Day 1 to Month 18
    16.3
    1.8%
    5. Secondary Outcome
    Title Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
    Description 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.
    Time Frame Baseline to end of treatment; median duration of treatment was 563 days.

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least 1 dose of etelcalcetide in the current study (20130213).
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Measure Participants 884
    Increased Alanine Aminotransferase Grade 1 to 3
    1
    0.1%
    Increased Alkaline Phosphatase Grade 1 to 3
    2
    0.2%
    Increased Aspartate Aminotransferase Grade 1 to 3
    1
    0.1%
    Decreased Corrected Calcium Grade 1 to 3
    18
    2%
    Decreased Corrected Calcium Grade 1 to 4
    2
    0.2%
    Decreased ionized Calcium Grade 1 to 3
    1
    0.1%
    Decreased ionized Calcium Grade 1 to 4
    2
    0.2%
    Decreased Phosphorous Grade 1 to 3
    1
    0.1%
    6. Secondary Outcome
    Title Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
    Description 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).
    Time Frame Baseline and every 6 months (up to 24 months)

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least 1 dose of etelcalcetide in the current study with a post-baseline antibody result during this study
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    Measure Participants 808
    Number [participants]
    111
    12.6%

    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.
    Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    Arm/Group Title Etelcalcetide
    Arm/Group Description 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.
    All Cause Mortality
    Etelcalcetide
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Etelcalcetide
    Affected / at Risk (%) # Events
    Total 436/884 (49.3%)
    Blood and lymphatic system disorders
    Anaemia 19/884 (2.1%)
    Coagulopathy 1/884 (0.1%)
    Haemorrhagic anaemia 1/884 (0.1%)
    Nephrogenic anaemia 2/884 (0.2%)
    Neutropenia 1/884 (0.1%)
    Thrombocytopenia 1/884 (0.1%)
    Cardiac disorders
    Acute coronary syndrome 2/884 (0.2%)
    Acute myocardial infarction 13/884 (1.5%)
    Angina pectoris 8/884 (0.9%)
    Angina unstable 4/884 (0.5%)
    Aortic valve incompetence 1/884 (0.1%)
    Aortic valve stenosis 2/884 (0.2%)
    Atrial fibrillation 15/884 (1.7%)
    Atrial flutter 3/884 (0.3%)
    Atrioventricular block complete 4/884 (0.5%)
    Bradycardia 3/884 (0.3%)
    Cardiac arrest 20/884 (2.3%)
    Cardiac failure 2/884 (0.2%)
    Cardiac failure acute 1/884 (0.1%)
    Cardiac failure congestive 8/884 (0.9%)
    Cardiac valve disease 1/884 (0.1%)
    Cardio-respiratory arrest 4/884 (0.5%)
    Cardiogenic shock 2/884 (0.2%)
    Cardiomyopathy 1/884 (0.1%)
    Coronary artery disease 7/884 (0.8%)
    Coronary artery stenosis 2/884 (0.2%)
    Mitral valve incompetence 1/884 (0.1%)
    Myocardial infarction 7/884 (0.8%)
    Myocardial ischaemia 5/884 (0.6%)
    Pericardial effusion 2/884 (0.2%)
    Pericarditis uraemic 1/884 (0.1%)
    Sinus node dysfunction 2/884 (0.2%)
    Sinus tachycardia 2/884 (0.2%)
    Supraventricular tachycardia 3/884 (0.3%)
    Ventricular tachycardia 2/884 (0.2%)
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease 4/884 (0.5%)
    Haemorrhagic arteriovenous malformation 1/884 (0.1%)
    Porencephaly 1/884 (0.1%)
    Ear and labyrinth disorders
    Vertigo 2/884 (0.2%)
    Endocrine disorders
    Adrenal insufficiency 1/884 (0.1%)
    Goitre 1/884 (0.1%)
    Hyperparathyroidism secondary 1/884 (0.1%)
    Hyperparathyroidism tertiary 1/884 (0.1%)
    Eye disorders
    Cataract 2/884 (0.2%)
    Optic ischaemic neuropathy 1/884 (0.1%)
    Vision blurred 1/884 (0.1%)
    Gastrointestinal disorders
    Abdominal hernia 1/884 (0.1%)
    Abdominal pain 7/884 (0.8%)
    Abdominal pain upper 1/884 (0.1%)
    Ascites 1/884 (0.1%)
    Chronic gastritis 2/884 (0.2%)
    Colitis 3/884 (0.3%)
    Colitis ischaemic 2/884 (0.2%)
    Constipation 1/884 (0.1%)
    Diarrhoea 7/884 (0.8%)
    Diverticular perforation 1/884 (0.1%)
    Diverticulum 1/884 (0.1%)
    Diverticulum intestinal haemorrhagic 1/884 (0.1%)
    Duodenal ulcer 1/884 (0.1%)
    Duodenitis 1/884 (0.1%)
    Enteritis 2/884 (0.2%)
    Epigastric discomfort 1/884 (0.1%)
    Gastric ulcer 1/884 (0.1%)
    Gastric ulcer haemorrhage 1/884 (0.1%)
    Gastritis haemorrhagic 1/884 (0.1%)
    Gastroduodenitis 2/884 (0.2%)
    Gastrointestinal haemorrhage 5/884 (0.6%)
    Haematemesis 1/884 (0.1%)
    Haematochezia 3/884 (0.3%)
    Haemorrhagic erosive gastritis 1/884 (0.1%)
    Haemorrhoidal haemorrhage 1/884 (0.1%)
    Hernial eventration 1/884 (0.1%)
    Ileus 1/884 (0.1%)
    Inguinal hernia 2/884 (0.2%)
    Intestinal ischaemia 2/884 (0.2%)
    Intestinal obstruction 1/884 (0.1%)
    Intestinal perforation 2/884 (0.2%)
    Large intestinal obstruction 1/884 (0.1%)
    Large intestine perforation 1/884 (0.1%)
    Large intestine polyp 1/884 (0.1%)
    Lower gastrointestinal haemorrhage 5/884 (0.6%)
    Nausea 4/884 (0.5%)
    Oesophagitis 1/884 (0.1%)
    Pancreatic disorder 1/884 (0.1%)
    Pancreatitis 4/884 (0.5%)
    Pancreatitis acute 5/884 (0.6%)
    Pancreatitis chronic 2/884 (0.2%)
    Rectal haemorrhage 1/884 (0.1%)
    Retroperitoneal haemorrhage 1/884 (0.1%)
    Small intestine polyp 1/884 (0.1%)
    Subileus 1/884 (0.1%)
    Upper gastrointestinal haemorrhage 6/884 (0.7%)
    Vomiting 5/884 (0.6%)
    General disorders
    Asthenia 5/884 (0.6%)
    Chest pain 7/884 (0.8%)
    Death 4/884 (0.5%)
    Drowning 1/884 (0.1%)
    Fatigue 1/884 (0.1%)
    General physical health deterioration 3/884 (0.3%)
    Hyperpyrexia 1/884 (0.1%)
    Impaired healing 2/884 (0.2%)
    Ischaemic ulcer 1/884 (0.1%)
    Malaise 1/884 (0.1%)
    Non-cardiac chest pain 11/884 (1.2%)
    Oedema peripheral 1/884 (0.1%)
    Pyrexia 11/884 (1.2%)
    Sudden death 4/884 (0.5%)
    Systemic inflammatory response syndrome 2/884 (0.2%)
    Hepatobiliary disorders
    Acute hepatic failure 1/884 (0.1%)
    Bile duct obstruction 1/884 (0.1%)
    Bile duct stone 3/884 (0.3%)
    Biliary colic 1/884 (0.1%)
    Cholangitis 2/884 (0.2%)
    Cholecystitis acute 7/884 (0.8%)
    Cholecystitis chronic 1/884 (0.1%)
    Cholelithiasis 3/884 (0.3%)
    Gallbladder disorder 1/884 (0.1%)
    Hepatic cyst 1/884 (0.1%)
    Hepatic cyst ruptured 1/884 (0.1%)
    Jaundice 1/884 (0.1%)
    Liver injury 1/884 (0.1%)
    Sphincter of Oddi dysfunction 1/884 (0.1%)
    Immune system disorders
    Chronic allograft nephropathy 1/884 (0.1%)
    Transplant rejection 2/884 (0.2%)
    Infections and infestations
    Abdominal abscess 1/884 (0.1%)
    Abdominal wall abscess 2/884 (0.2%)
    Abscess limb 1/884 (0.1%)
    Appendicitis 1/884 (0.1%)
    Appendicitis perforated 1/884 (0.1%)
    Arteriovenous fistula site infection 3/884 (0.3%)
    Arteriovenous graft site abscess 1/884 (0.1%)
    Arteriovenous graft site infection 3/884 (0.3%)
    Arthritis bacterial 2/884 (0.2%)
    Bacteraemia 3/884 (0.3%)
    Bacterial sepsis 2/884 (0.2%)
    Bronchitis 10/884 (1.1%)
    Bronchitis bacterial 1/884 (0.1%)
    Campylobacter gastroenteritis 1/884 (0.1%)
    Catheter site infection 1/884 (0.1%)
    Cellulitis 9/884 (1%)
    Cellulitis gangrenous 1/884 (0.1%)
    Cellulitis orbital 1/884 (0.1%)
    Citrobacter sepsis 1/884 (0.1%)
    Clostridium difficile colitis 3/884 (0.3%)
    Device related infection 7/884 (0.8%)
    Device related sepsis 4/884 (0.5%)
    Diabetic foot infection 2/884 (0.2%)
    Diabetic gangrene 1/884 (0.1%)
    Diverticulitis 1/884 (0.1%)
    Ear infection 1/884 (0.1%)
    Endocarditis 7/884 (0.8%)
    Epiglottitis 1/884 (0.1%)
    Erysipelas 2/884 (0.2%)
    Escherichia sepsis 2/884 (0.2%)
    Febrile infection 1/884 (0.1%)
    Gangrene 9/884 (1%)
    Gastroenteritis 7/884 (0.8%)
    Helicobacter gastritis 1/884 (0.1%)
    Hepatitis A 1/884 (0.1%)
    Herpes zoster 3/884 (0.3%)
    Infection 2/884 (0.2%)
    Influenza 3/884 (0.3%)
    Intervertebral discitis 3/884 (0.3%)
    Intestinal tuberculosis 1/884 (0.1%)
    Laryngitis 1/884 (0.1%)
    Liver abscess 1/884 (0.1%)
    Localised infection 3/884 (0.3%)
    Lower respiratory tract infection 4/884 (0.5%)
    Lower respiratory tract infection viral 1/884 (0.1%)
    Mediastinitis 1/884 (0.1%)
    Meningitis 1/884 (0.1%)
    Muscle abscess 1/884 (0.1%)
    Orchitis 1/884 (0.1%)
    Osteomyelitis 11/884 (1.2%)
    Osteomyelitis chronic 1/884 (0.1%)
    Perineal abscess 1/884 (0.1%)
    Pneumonia 40/884 (4.5%)
    Post procedural infection 1/884 (0.1%)
    Postoperative wound infection 1/884 (0.1%)
    Pseudomembranous colitis 1/884 (0.1%)
    Pulmonary sepsis 1/884 (0.1%)
    Pyelonephritis 1/884 (0.1%)
    Respiratory tract infection 7/884 (0.8%)
    Respiratory tract infection viral 3/884 (0.3%)
    Sepsis 27/884 (3.1%)
    Septic shock 14/884 (1.6%)
    Serratia bacteraemia 1/884 (0.1%)
    Sinusitis 1/884 (0.1%)
    Skin infection 1/884 (0.1%)
    Staphylococcal bacteraemia 3/884 (0.3%)
    Staphylococcal sepsis 1/884 (0.1%)
    Stoma site infection 1/884 (0.1%)
    Subcutaneous abscess 2/884 (0.2%)
    Systemic infection 1/884 (0.1%)
    Tracheitis 1/884 (0.1%)
    Tracheobronchitis 1/884 (0.1%)
    Urinary tract infection 6/884 (0.7%)
    Urosepsis 3/884 (0.3%)
    Vascular access site infection 1/884 (0.1%)
    Viral infection 2/884 (0.2%)
    Vulval abscess 1/884 (0.1%)
    Wound infection 3/884 (0.3%)
    Injury, poisoning and procedural complications
    Acetabulum fracture 1/884 (0.1%)
    Ankle fracture 1/884 (0.1%)
    Arteriovenous fistula aneurysm 1/884 (0.1%)
    Arteriovenous fistula occlusion 1/884 (0.1%)
    Arteriovenous fistula site complication 11/884 (1.2%)
    Arteriovenous fistula site haematoma 1/884 (0.1%)
    Arteriovenous fistula site haemorrhage 4/884 (0.5%)
    Arteriovenous fistula thrombosis 24/884 (2.7%)
    Arteriovenous graft site haemorrhage 1/884 (0.1%)
    Arteriovenous graft thrombosis 9/884 (1%)
    Cervical vertebral fracture 1/884 (0.1%)
    Contusion 1/884 (0.1%)
    Craniocerebral injury 1/884 (0.1%)
    Fall 7/884 (0.8%)
    Femur fracture 2/884 (0.2%)
    Hip fracture 2/884 (0.2%)
    Joint dislocation 1/884 (0.1%)
    Laceration 1/884 (0.1%)
    Limb injury 4/884 (0.5%)
    Lower limb fracture 1/884 (0.1%)
    Lumbar vertebral fracture 1/884 (0.1%)
    Overdose 1/884 (0.1%)
    Patella fracture 1/884 (0.1%)
    Pelvic fracture 1/884 (0.1%)
    Post procedural haemorrhage 2/884 (0.2%)
    Post-traumatic pain 1/884 (0.1%)
    Procedural hypertension 1/884 (0.1%)
    Procedural hypotension 3/884 (0.3%)
    Procedural intestinal perforation 1/884 (0.1%)
    Procedural pain 3/884 (0.3%)
    Radius fracture 1/884 (0.1%)
    Rib fracture 1/884 (0.1%)
    Road traffic accident 1/884 (0.1%)
    Shunt aneurysm 1/884 (0.1%)
    Shunt occlusion 2/884 (0.2%)
    Shunt stenosis 1/884 (0.1%)
    Spinal compression fracture 1/884 (0.1%)
    Subarachnoid haemorrhage 4/884 (0.5%)
    Subdural haematoma 1/884 (0.1%)
    Tendon rupture 1/884 (0.1%)
    Thermal burn 1/884 (0.1%)
    Tibia fracture 1/884 (0.1%)
    Toxicity to various agents 1/884 (0.1%)
    Tracheostomy malfunction 1/884 (0.1%)
    Upper limb fracture 1/884 (0.1%)
    Vascular access complication 5/884 (0.6%)
    Vascular access malfunction 2/884 (0.2%)
    Vascular graft complication 2/884 (0.2%)
    Vascular graft occlusion 1/884 (0.1%)
    Vascular injury 1/884 (0.1%)
    Vascular pseudoaneurysm ruptured 2/884 (0.2%)
    Wound 1/884 (0.1%)
    Wound dehiscence 1/884 (0.1%)
    Investigations
    Blood potassium decreased 1/884 (0.1%)
    Paracentesis 1/884 (0.1%)
    Peripheral pulse decreased 1/884 (0.1%)
    Metabolism and nutrition disorders
    Calciphylaxis 2/884 (0.2%)
    Dehydration 2/884 (0.2%)
    Electrolyte imbalance 1/884 (0.1%)
    Fluid overload 16/884 (1.8%)
    Fluid retention 2/884 (0.2%)
    Hyperglycaemia 1/884 (0.1%)
    Hyperinsulinaemic hypoglycaemia 1/884 (0.1%)
    Hyperkalaemia 16/884 (1.8%)
    Hypervolaemia 2/884 (0.2%)
    Hypoglycaemia 4/884 (0.5%)
    Hyponatraemia 1/884 (0.1%)
    Metabolic acidosis 1/884 (0.1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 6/884 (0.7%)
    Arthritis reactive 1/884 (0.1%)
    Back pain 4/884 (0.5%)
    Cervical spinal stenosis 1/884 (0.1%)
    Chondrocalcinosis 1/884 (0.1%)
    Fracture nonunion 1/884 (0.1%)
    Intervertebral disc degeneration 1/884 (0.1%)
    Muscle spasms 2/884 (0.2%)
    Muscle swelling 1/884 (0.1%)
    Muscular weakness 1/884 (0.1%)
    Musculoskeletal chest pain 3/884 (0.3%)
    Musculoskeletal pain 1/884 (0.1%)
    Myalgia 2/884 (0.2%)
    Neck pain 1/884 (0.1%)
    Neuropathic arthropathy 1/884 (0.1%)
    Pain in extremity 6/884 (0.7%)
    Pseudarthrosis 1/884 (0.1%)
    SLE arthritis 1/884 (0.1%)
    Spinal column stenosis 1/884 (0.1%)
    Spinal osteoarthritis 1/884 (0.1%)
    Tendon calcification 1/884 (0.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 1/884 (0.1%)
    Benign neoplasm 1/884 (0.1%)
    Benign neoplasm of bladder 1/884 (0.1%)
    Bladder cancer 1/884 (0.1%)
    Bladder papilloma 1/884 (0.1%)
    Breast cancer 1/884 (0.1%)
    Carcinoid tumour of the small bowel 1/884 (0.1%)
    Endometrial adenocarcinoma 2/884 (0.2%)
    Lung adenocarcinoma metastatic 1/884 (0.1%)
    Malignant melanoma 1/884 (0.1%)
    Prostate cancer 1/884 (0.1%)
    Renal cell carcinoma 2/884 (0.2%)
    Nervous system disorders
    Altered state of consciousness 1/884 (0.1%)
    Aphasia 1/884 (0.1%)
    Brain injury 2/884 (0.2%)
    Brain stem stroke 1/884 (0.1%)
    Carotid artery occlusion 1/884 (0.1%)
    Carotid artery stenosis 4/884 (0.5%)
    Carpal tunnel syndrome 1/884 (0.1%)
    Cerebral haemorrhage 5/884 (0.6%)
    Cerebral infarction 2/884 (0.2%)
    Cerebral ischaemia 2/884 (0.2%)
    Cerebrovascular accident 7/884 (0.8%)
    Diabetic neuropathy 1/884 (0.1%)
    Dizziness 3/884 (0.3%)
    Dysaesthesia 1/884 (0.1%)
    Dysarthria 1/884 (0.1%)
    Encephalopathy 3/884 (0.3%)
    Epilepsy 2/884 (0.2%)
    Facial paresis 1/884 (0.1%)
    Haemorrhage intracranial 1/884 (0.1%)
    Haemorrhagic stroke 3/884 (0.3%)
    Headache 1/884 (0.1%)
    Hypersomnia 1/884 (0.1%)
    Hypoaesthesia 2/884 (0.2%)
    Hypoxic-ischaemic encephalopathy 1/884 (0.1%)
    Loss of consciousness 2/884 (0.2%)
    Metabolic encephalopathy 3/884 (0.3%)
    Multiple sclerosis 1/884 (0.1%)
    Neuritis cranial 1/884 (0.1%)
    Normal pressure hydrocephalus 1/884 (0.1%)
    Paraesthesia 1/884 (0.1%)
    Presyncope 2/884 (0.2%)
    Quadriplegia 1/884 (0.1%)
    Seizure 2/884 (0.2%)
    Syncope 13/884 (1.5%)
    Transient global amnesia 1/884 (0.1%)
    Transient ischaemic attack 4/884 (0.5%)
    Tremor 1/884 (0.1%)
    Uraemic neuropathy 1/884 (0.1%)
    Product Issues
    Device dislocation 2/884 (0.2%)
    Device failure 1/884 (0.1%)
    Device malfunction 1/884 (0.1%)
    Device occlusion 1/884 (0.1%)
    Stent malfunction 1/884 (0.1%)
    Thrombosis in device 6/884 (0.7%)
    Psychiatric disorders
    Anxiety 1/884 (0.1%)
    Confusional state 2/884 (0.2%)
    Delirium 3/884 (0.3%)
    Depression 3/884 (0.3%)
    Depression suicidal 1/884 (0.1%)
    Insomnia 1/884 (0.1%)
    Mental status changes 8/884 (0.9%)
    Suicide attempt 1/884 (0.1%)
    Renal and urinary disorders
    End stage renal disease 1/884 (0.1%)
    Haematuria 1/884 (0.1%)
    Hydronephrosis 1/884 (0.1%)
    Nephrolithiasis 1/884 (0.1%)
    Renal colic 1/884 (0.1%)
    Renal cyst 2/884 (0.2%)
    Renal cyst haemorrhage 1/884 (0.1%)
    Renal failure 1/884 (0.1%)
    Renal vein thrombosis 1/884 (0.1%)
    Urethral stenosis 3/884 (0.3%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/884 (0.1%)
    Postmenopausal haemorrhage 1/884 (0.1%)
    Priapism 1/884 (0.1%)
    Uterine polyp 2/884 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 3/884 (0.3%)
    Acute respiratory failure 3/884 (0.3%)
    Bullous lung disease 1/884 (0.1%)
    Choking 1/884 (0.1%)
    Chronic obstructive pulmonary disease 4/884 (0.5%)
    Dependence on respirator 1/884 (0.1%)
    Dyspnoea 12/884 (1.4%)
    Epistaxis 3/884 (0.3%)
    Haemothorax 1/884 (0.1%)
    Hydrothorax 2/884 (0.2%)
    Hypoxia 6/884 (0.7%)
    Orthopnoea 1/884 (0.1%)
    Pleural effusion 3/884 (0.3%)
    Pneumonia aspiration 1/884 (0.1%)
    Pulmonary embolism 1/884 (0.1%)
    Pulmonary oedema 12/884 (1.4%)
    Respiratory arrest 1/884 (0.1%)
    Respiratory failure 4/884 (0.5%)
    Skin and subcutaneous tissue disorders
    Diabetic foot 2/884 (0.2%)
    Skin discolouration 1/884 (0.1%)
    Skin ulcer 1/884 (0.1%)
    Vascular disorders
    Accelerated hypertension 1/884 (0.1%)
    Aortic aneurysm 1/884 (0.1%)
    Aortic dissection 2/884 (0.2%)
    Aortic stenosis 1/884 (0.1%)
    Arterial occlusive disease 1/884 (0.1%)
    Arteriosclerosis 1/884 (0.1%)
    Arteriovenous fistula 1/884 (0.1%)
    Axillary vein thrombosis 1/884 (0.1%)
    Deep vein thrombosis 1/884 (0.1%)
    Exsanguination 1/884 (0.1%)
    Extremity necrosis 3/884 (0.3%)
    Haematoma 4/884 (0.5%)
    Hypertension 9/884 (1%)
    Hypertensive crisis 6/884 (0.7%)
    Hypertensive emergency 1/884 (0.1%)
    Hypotension 8/884 (0.9%)
    Hypovolaemic shock 1/884 (0.1%)
    Iliac artery occlusion 1/884 (0.1%)
    Malignant hypertension 1/884 (0.1%)
    Orthostatic hypotension 3/884 (0.3%)
    Peripheral arterial occlusive disease 1/884 (0.1%)
    Peripheral artery aneurysm 1/884 (0.1%)
    Peripheral artery occlusion 1/884 (0.1%)
    Peripheral artery stenosis 1/884 (0.1%)
    Peripheral artery thrombosis 1/884 (0.1%)
    Peripheral ischaemia 7/884 (0.8%)
    Peripheral vascular disorder 4/884 (0.5%)
    Shock haemorrhagic 1/884 (0.1%)
    Steal syndrome 2/884 (0.2%)
    Superior vena cava stenosis 1/884 (0.1%)
    Superior vena cava syndrome 2/884 (0.2%)
    Thrombophlebitis 1/884 (0.1%)
    Vascular calcification 1/884 (0.1%)
    Vascular compression 1/884 (0.1%)
    Venous occlusion 1/884 (0.1%)
    Other (Not Including Serious) Adverse Events
    Etelcalcetide
    Affected / at Risk (%) # Events
    Total 519/884 (58.7%)
    Gastrointestinal disorders
    Diarrhoea 84/884 (9.5%)
    Nausea 58/884 (6.6%)
    Vomiting 55/884 (6.2%)
    Infections and infestations
    Upper respiratory tract infection 58/884 (6.6%)
    Investigations
    Blood calcium decreased 251/884 (28.4%)
    Metabolism and nutrition disorders
    Hyperphosphataemia 81/884 (9.2%)
    Musculoskeletal and connective tissue disorders
    Back pain 51/884 (5.8%)
    Muscle spasms 73/884 (8.3%)
    Pain in extremity 59/884 (6.7%)
    Respiratory, thoracic and mediastinal disorders
    Cough 49/884 (5.5%)
    Dyspnoea 49/884 (5.5%)
    Vascular disorders
    Hypertension 62/884 (7%)
    Hypotension 59/884 (6.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

    Results Point of Contact

    Name/Title Study Director
    Organization Amgen Inc.
    Phone 866-572-6436
    Email
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT02102204
    Other Study ID Numbers:
    • 20130213
    • 2013-004136-30
    • KAI-4169
    First Posted:
    Apr 2, 2014
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Oct 1, 2017