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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
KAI-4169-008
Secondary ID [2] 0 0
20120231
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Secondary 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From first dose until 30 days after last dose; the treatment period was 52 weeks.
Primary outcome [2] 0 0
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4
Timepoint [2] 0 0
52 weeks
Primary outcome [3] 0 0
Number of Participants Who Developed Anti-etelcalcetide Antibodies
Timepoint [3] 0 0
Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Primary outcome [4] 0 0
Change From Baseline in Blood Pressure
Timepoint [4] 0 0
Baseline and Weeks 24 and 48
Secondary outcome [1] 0 0
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12
Timepoint [2] 0 0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary outcome [3] 0 0
Percentage of Participants With PTH = 300 pg/mL During the EAP
Timepoint [3] 0 0
Baseline and the efficacy assessment phase
Secondary outcome [4] 0 0
Percentage of Participants With PTH = 300 pg/mL During the EAP12
Timepoint [4] 0 0
Week 46 to 53
Secondary outcome [5] 0 0
Percent Change From Baseline in Mean PTH During the EAP
Timepoint [5] 0 0
Baseline and the efficacy assessment phase
Secondary outcome [6] 0 0
Percent Change From Baseline in Mean PTH During the EAP12
Timepoint [6] 0 0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary outcome [7] 0 0
Percent Change From Baseline in Mean Corrected Calcium During the EAP
Timepoint [7] 0 0
Baseline and the efficacy assessment phase
Secondary outcome [8] 0 0
Percent Change From Baseline in Mean Corrected Calcium During the EAP12
Timepoint [8] 0 0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary outcome [9] 0 0
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP
Timepoint [9] 0 0
Baseline and the efficacy assessment phase
Secondary outcome [10] 0 0
Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12
Timepoint [10] 0 0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)
Secondary outcome [11] 0 0
Percent Change From Baseline in Mean Phosphorus During the EAP
Timepoint [11] 0 0
Baseline and the efficacy assessment phase
Secondary outcome [12] 0 0
Percent Change From Baseline in Mean Phosphorus During the EAP12
Timepoint [12] 0 0
Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
891
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Research Site - Liverpool
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Research Site - Clayton
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Research Site - Parkville
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2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01785875
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.
Bushinsky DA, Chertow GM, Cheng S, Deng H, Kopyt N, Martin KJ, Rastogi A, Urena-Torres P, Vervloet M, Block GA. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039. Erratum In: Nephrol Dial Transplant. 2019 May 15:1642. doi: 10.1093/ndt/gfz111.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01785875