Chronic Kidney Disease, Secondary HyperparathyroidismPhase 1NCT02833857

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

A Phase 1 study testing Etelcalcetide in people with Chronic Kidney Disease, Secondary Hyperparathyroidism, run by Amgen at 13 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Chronic Kidney Disease, Secondary Hyperparathyroidism
What is being tested?: Etelcalcetide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 13 sitesin 6 countries
Study dates: 14 Mar 2017to 31 Oct 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject's parent has provided informed consent and subject has provided assent
Children Age 2 to less than 18 years
Diagnosed with chronic kidney disease
Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
Weighing at least 7 kg
Laboratory results within specified range.

Who cannot join

Currently receiving treatment in another investigation device or drug study
Subject has received cinacalcet therapy within 30 days
History of prolongation QT interval
Subject is taking any medications that are on the QT prolongation medication list
Electrocardiograph (ECG) measurements within specified range.

Trial locations and contacts

13 sites in 6 countries.

Country

City, postcode or hospital

13 sites in 6 countries

Germany4 sites

Research Site
Cologne, 50937
Research Site
Hanover, 30625
Research Site
Heidelberg, 69120
Research Site
Marburg, 35043

Other trials in Germany

United States3 sites

Research Site
Kansas City, Missouri, 64108
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202

Other trials in United States

Belgium3 sites

Research Site
Brussels, 1020
Research Site
Ghent, 9000
Research Site
Leuven, 3000

Other trials in Belgium

Lithuania1 site

Research Site
Vilinus, 08406

Other trials in Lithuania

Poland1 site

Research Site
Krakow, 30-663

Other trials in Poland

United Kingdom1 site

Research Site
London, WC1N 3JH

Other trials in United Kingdom

About this study

Official title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.

Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Being tested: Etelcalcetide
Keywords: Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EtelcalcetideDrug
Also called AMG 416, Parsabiv
A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.

Study groups in NCT02833857
Study group	Role	What they receive
Etelcalcetide	Experimental	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1. Receives: Drug: Etelcalcetide

What is being measured

The primary outcome is the main question the study is designed to answer.

Common Treatment-emergent Adverse Events
A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose.
Common adverse events were defined as adverse events occurring in at least 2 participants.
The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.
Measured: 30 days
Change From Baseline in Serum Corrected Calcium Concentration Over Time
When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin [g/L]).
Measured: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Change From Baseline in Serum Phosphorus Concentration at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in Serum Potassium Concentration at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
Measured: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Change From Baseline in Heart Rate at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in Temperature at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in Blood Pressure at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in PR Interval at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in QRS Interval at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in QT Interval at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Bazett) QT Interval at End of Study
Measured: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
Measured: Baseline and day 30 (end of study)

Secondary outcomes (9)

Change From Baseline in Serum Total Calcium Concentration
Measured: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Change From Baseline in Serum Ionized Calcium Concentration
Measured: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Measured: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Time to Maximum Concentration (Tmax) of Etelcalcetide
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Measured: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method.
Measured: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method.
Measured: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Terminal Half-life (T1/2,z) of Etelcalcetide
Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase.
Measured: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies
Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay.
Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline.
Measured: Baseline and day 30
Number of Participants With Treatment-emergent Adverse Events
A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 201731 Oct 2018

First posted14 Jul 2016 (estimated)
Study start14 Mar 2017
Primary completion31 Oct 2018
Study completion31 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney Disease, Secondary HyperparathyroidismStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02833857
Sponsor's protocol ID: 20140336
Other IDs: 2015-005051-28, 2015
Status last verified: Apr 2019
First submitted: 9 Jun 2016
Last updated: 10 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

Sohn W, Salusky IB, Schmitt CP, Taylan C, Walle JV, Ngang J, Yan L, Kroenke M, Warady BA. Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis. Pediatr Nephrol. 2021 Jan;36(1):133-142. doi: 10.1007/s00467-020-04599-z. Epub 2020 Jul 9.
PubMed 32647975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease, Secondary Hyperparathyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
ClinicalTrials.gov ID: NCT02833857
Acronym / sponsor ID: 20140336
Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 14 Mar 2017 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 14 Jul 2016 (estimated)
Results: Posted 10 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Etelcalcetide	Experimental	Drug: EtelcalcetideParticipants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subject's parent has provided informed consent and subject has provided assent
Children Age 2 to less than 18 years
Diagnosed with chronic kidney disease
Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
Weighing at least 7 kg

Key exclusion criteria (5 listed)

Currently receiving treatment in another investigation device or drug study
Subject has received cinacalcet therapy within 30 days
History of prolongation QT interval
Subject is taking any medications that are on the QT prolongation medication list
Electrocardiograph (ECG) measurements within specified range.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EtelcalcetideAlso: AMG 416, ParsabivA single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.	Drug	Etelcalcetide

Primary outcome

Common Treatment-emergent Adverse Events
Time frame: 30 days
A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. Common adverse events were defined as adverse events occurring in at least 2 participants. The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.
Change From Baseline in Serum Corrected Calcium Concentration Over Time
Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin [g/L]).
Change From Baseline in Serum Phosphorus Concentration at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Serum Potassium Concentration at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
Time frame: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Change From Baseline in Heart Rate at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Temperature at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Blood Pressure at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in PR Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in QRS Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Bazett) QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
Time frame: Baseline and day 30 (end of study)

9 secondary outcomes

Change From Baseline in Serum Total Calcium Concentration
Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Change From Baseline in Serum Ionized Calcium Concentration
Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Time to Maximum Concentration (Tmax) of Etelcalcetide
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Terminal Half-life (T1/2,z) of Etelcalcetide
Time frame: 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies
Time frame: Baseline and day 30
Number of Participants With Treatment-emergent Adverse Events
Time frame: 30 days

Results and safety

Results posted to the registry on 10 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etelcalcetide	11	11

Primary outcome: Common Treatment-emergent Adverse Events

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Etelcalcetide n = 11
Headache	2
Calcium ionised decreased	2
Hypotension	2

Population analysed: Participants who received at least 1 dose of etelcalcetide (safety analysis set)

Primary outcome: Change From Baseline in Serum Corrected Calcium Concentration Over Time

Time frame: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study). Mean (Standard Deviation). Unit: mmol/L

Measure	Etelcalcetide n = 11
Day 1, 4 hours	-0.03 (0.12)
Day 3	-0.03 (0.08)
Day 8	0.03 (0.09)
Day 10	0.03 (0.07)
Day 30	-0.01 (0.16)

Population analysed: Treated participants with available data at each time point.

Primary outcome: Change From Baseline in Serum Phosphorus Concentration at End of Study

Time frame: Baseline and day 30 (end of study). Mean (Standard Deviation). Unit: mmol/L

Measure	Etelcalcetide n = 11
Value	0.08 (0.31)

Population analysed: Treated participants

Primary outcome: Change From Baseline in Serum Potassium Concentration at End of Study

Time frame: Baseline and day 30 (end of study). Mean (Standard Deviation). Unit: mmol/L

Measure	Etelcalcetide n = 11
Value	0.45 (1.21)

Population analysed: Treated participants

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etelcalcetide	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32647975Sohn W, Salusky IB, Schmitt CP, Taylan C, Walle JV, Ngang J, Yan L, Kroenke M, Warady BA. Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis. Pediatr Nephrol. 2021 Jan;36(1):133-142. doi: 10.1007/s00467-020-04599-z. Epub 2020 Jul 9.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Related trials for Chronic Kidney Disease, Secondary Hyperparathyroidism

Not yet recruitingPhase 3
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Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

13 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etelcalcetide in people with Chronic Kidney Disease, Secondary Hyperparathyroidism, run by Amgen at 13 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, United States, Belgium, Lithuania, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Common Treatment-emergent Adverse Events (time frame: 30 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.