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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/NCT01785875
Registration number
NCT01785875
Ethics application status
Date submitted
5/02/2013
Date registered
7/02/2013
Date last updated
10/04/2019
Titles & IDs
Public title
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
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Scientific 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
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Secondary ID [1]
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KAI-4169-008
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Secondary ID [2]
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20120231
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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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Kidney disease
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Renal and Urogenital
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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 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.
Treatment: Drugs: 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).
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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 (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose until 30 days after last dose; the treatment period was 52 weeks.
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Primary outcome [2]
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Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
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Assessment method [2]
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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.
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Timepoint [2]
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52 weeks
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Primary outcome [3]
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Number of Participants Who Developed Anti-etelcalcetide Antibodies
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
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Primary outcome [4]
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Change From Baseline in Blood Pressure
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Assessment method [4]
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Blood pressure (BP) values were taken post-hemodialysis assessments.
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Timepoint [4]
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Baseline and Weeks 24 and 48
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Secondary outcome [1]
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Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
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Assessment method [1]
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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.
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Timepoint [1]
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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)
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Secondary outcome [2]
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Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
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Secondary outcome [3]
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Percentage of Participants With PTH = 300 pg/mL During the EAP
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Assessment method [3]
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Timepoint [3]
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Baseline and the efficacy assessment phase
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Secondary outcome [4]
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Percentage of Participants With PTH = 300 pg/mL During the EAP12
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Assessment method [4]
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Timepoint [4]
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Week 46 to 53
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Secondary outcome [5]
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Percent Change From Baseline in Mean PTH During the EAP
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Assessment method [5]
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Timepoint [5]
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Baseline and the efficacy assessment phase
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Secondary outcome [6]
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Percent Change From Baseline in Mean PTH During the EAP12
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Assessment method [6]
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Timepoint [6]
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Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
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Secondary outcome [7]
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Percent Change From Baseline in Mean Corrected Calcium During the EAP
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Assessment method [7]
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Timepoint [7]
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Baseline and the efficacy assessment phase
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Secondary outcome [8]
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Percent Change From Baseline in Mean Corrected Calcium During the EAP12
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Assessment method [8]
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Timepoint [8]
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Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
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Secondary outcome [9]
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Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
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Assessment method [9]
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Timepoint [9]
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Baseline and the efficacy assessment phase
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Secondary outcome [10]
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Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
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Assessment method [10]
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Timepoint [10]
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Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
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Secondary outcome [11]
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Percent Change From Baseline in Mean Phosphorus During the EAP
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Assessment method [11]
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Timepoint [11]
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Baseline and the efficacy assessment phase
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Secondary outcome [12]
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Percent Change From Baseline in Mean Phosphorus During the EAP12
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Assessment method [12]
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Timepoint [12]
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Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
100
Years
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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.
- 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
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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
31/07/2013
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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
1/07/2015
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Sample size
Target
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Accrual to date
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Final
891
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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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Recruitment hospital [2]
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Research Site - St Leonards
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Research Site - Adelaide
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Recruitment hospital [6]
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Research Site - Clayton
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Recruitment hospital [7]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4102 - Brisbane
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment outside Australia
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Spain
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Andalucía
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Spain
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Cantabria
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Country [107]
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Spain
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Cataluña
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Country [108]
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Spain
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Madrid
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Sweden
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Karlstad
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Country [110]
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Cambridge
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United Kingdom
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Coventry
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01785875
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Trial related presentations / publications
Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
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Public notes
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Contacts
Principal investigator
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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/NCT01785875
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