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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02102204
Registration number
NCT02102204
Ethics application status
Date submitted
3/03/2014
Date registered
2/04/2014
Date last updated
17/11/2017
Titles & IDs
Public title
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
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Scientific 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
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Secondary ID [1]
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2013-004136-30
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Secondary ID [2]
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20130213
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Secondary
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
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0
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0
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Other renal and urogenital disorders
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Metabolic and Endocrine
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0
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etelcalcetide
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.
Treatment: Drugs: Etelcalcetide
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
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Assessment method [1]
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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.
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Timepoint [1]
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Months 6, 12, and 18
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Secondary outcome [2]
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Percentage of Participants With Serum Phosphorus = the ULN
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Assessment method [2]
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Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
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Timepoint [2]
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Months 6, 12, and 18
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Secondary outcome [3]
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Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
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Assessment method [3]
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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.
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Timepoint [3]
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From day 1 to months 6, 12, and 18
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Secondary outcome [4]
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Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to end of treatment; median duration of treatment was 563 days.
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Secondary outcome [5]
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Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline and every 6 months (up to 24 months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
110
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/06/2017
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Sample size
Target
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Accrual to date
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Final
902
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Liverpool
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Research Site - Clayton
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Research Site - Prahan
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2170 - Liverpool
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2145 - Westmead
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3004 - Prahan
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Recruitment outside Australia
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Golub-Dobrzyn
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Krakow
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Mitishi
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Funding & Sponsors
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Commercial sector/Industry
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Name
Amgen
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02102204
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Contacts
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MD
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02102204
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