Secondary HyperparathyroidismPhase 3NCT03969329
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
A Phase 3 study testing Etelcalcetide in people with Secondary Hyperparathyroidism, run by Amgen at 23 sites in 12 countries.
Trial summary
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Etelcalcetide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 23 sitesin 12 countries
- Study dates
- 20 Dec 2019to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any trial-specific activities/procedures being initiated.
- Male or female participants greater than or equal to 2 to less than 18 years of age at the time of enrollment.
- Targeted dry weight greater than or equal to 7 kg at the time of screening Week -1.
- Diagnosed with CKD and SHPT undergoing hemodialysis/hemodiafiltration TIW or four times a week (QIW) at the time of screening greater than or equal to 1 month.
- Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values greater than 300 pg/mL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening.
- Serum corrected Ca value greater than or equal to 9.0 mg/dL obtained from the central laboratory during screening.
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- Dialysate Ca level greater than or equal to 2.5 mEq/L for at least 1 month prior to screening and throughout the duration of the trial.
- participant receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable doses for the duration of the trial, except for adjustments allowed per protocol.
- participant receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.
- Subject receiving Ca supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.
- SHPT not due to vitamin D deficiency, per investigator assessment.
Who cannot join
- Disease Related:
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval.
- Anticipated or scheduled parathyroidectomy during the trial period.
- Anticipated or scheduled kidney transplant during the trial period.
- Participant has received a parathyroidectomy within 6 months prior to enrollment.
- Other Medical Conditions:
Show all 35Show fewer
- Current malignancy or history of other malignancy, except non-melanoma skin cancers within the last 5 years.
- Prior/Concomitant Therapy:
- Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance. Certain medications may be allowed based on review by the Medical Monitor and require additional electrocardiogram (ECG) monitoring and potential electrolyte monitoring.
- Receipt of cinacalcet therapy within 30 days prior to screening and through enrollment.
- Any previous use of etelcalcetide prior to screening and through enrollment (Original protocol, Amendment 1, and Amendment 2 only).
- Receipt of etelcalcetide therapy within 6 months prior to screening assessments and through enrollment (Amendment 3 and later only).
- All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation.
- Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to enrollment that are not established therapies for participants with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation. Paracetamol for analgesia will be allowed.
- Prior/Concurrent Clinical Trial Experience:
- Currently receiving treatment in another investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded.
- Diagnostic Assessments During Screening:
- Participant has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase [ALT] or serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST], or serum glutamic oxaloacetic transaminase [SGOT]) greater than 1.5 times the upper limit of normal (ULN).
- Corrected QT interval greater than 500 ms, using Bazett's formula.
- Corrected QT interval greater than or equal to 450 to less than or equal to 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist.
- Participant has a clinically significant ECG abnormality (eg, unstable arrhythmia) during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation.
- Within the 3 Months Prior to Screening:
- New onset or worsening of a pre-existing seizure disorder.
- Participants on anti-convulsant medication must be on a stable and therapeutic dose for 3 months prior to screening (if blood level monitoring is clinically available, then the participant must have a therapeutic blood level within 1 week of enrollment).
- Other Exclusions:
- Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the trial after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product).
- Female participants of childbearing potential unwilling to use 1 highly effective or acceptable method of effective contraception during treatment and for an additional 3 months after the last dose of investigational product.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.
- Participant has known sensitivity to etelcalcetide or excipients to be administered during dosing.
- Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) or unacceptable physical findings, that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the trial evaluation procedures or completion.
- Participant has previously entered this trial or previously received treatment with etelcalcetide (Original protocol, Amendment 1 and Amendment 2 only).
- Participant previously has entered this trial (Amendment 3 and later only).
- Anemia, which in the opinion of the investigator makes it not advisable to undergo sequential blood draws.
- History of unstable chronic heart failure within the last 1 year prior to screening.
Trial locations and contacts
23 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 12 countries
Germany5 sites, 3 recruiting
- Completed
Kindernierenzentrum Bonn
Bonn, 53127
- Recruiting
Universitaetsklinikum Koeln
Cologne, 50937
- Recruiting
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
- Completed
Medizinische Hochschule Hannover
Hanover, 30625
- Recruiting
Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin
Heidelberg, 69120
United Kingdom4 sites, 3 recruiting
- Recruiting
Royal Hospital for Sick Children
Glasgow, G51 4TF
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
- Terminated
Great Ormond Street Hospital for Children
London, WC1N 3JH
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
France2 sites
- Terminated
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, 69677
- Completed
Hopital Armand Trousseau
Paris, 75012
Greece2 sites, 2 recruiting
- Recruiting
General Children Hospital Panagioti and Aglaias Kyriakou
Athens, 11527
- Recruiting
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 54642
Hungary2 sites
- Terminated
Semmelweis Egyetem
Budapest, 1083
- Terminated
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6720
Spain2 sites, 1 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
- Terminated
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Lithuania1 site
- Terminated
Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
Vilinus, 08406
Poland1 site
- Terminated
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30-663
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, 4050-651
About this study
Official title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Etelcalcetide
- Keywords
- Secondary hyperparathyroidism (sHPT), Chronic kidney disease (CKD), Paediatric
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtelcalcetideDrug
Also called Parsabiv - brand name
Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, calcium (Ca), and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe.
| Study group | Role | What they receive |
|---|---|---|
| Etelcalcetide | Experimental | Participants will receive etelcalcetide in addition to standard of care. Receives: Drug: Etelcalcetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in iPTH at Weeks 20 to 26
To evaluate the efficacy of etelcalcetide in reducing the iPTH level in children ages equal to or greater than 2 to less than 18 years with SHPT receiving maintenance hemodialysis.
Measured: Week 20 to 26
Secondary outcomes (8)
Number of Participants Who Achieve a >30% Reduction From Baseline in Mean iPTH
To evaluate the efficacy of etelcalcetide.
Measured: Week 20 to 26
Percent Change From Baseline in Corrected Total Serum Ca and Serum Phosphorus
To characterize change in laboratory markers of chronic kidney disease.
Measured: Week 20 to 26
Proportion of Participants Achieving Corrected Serum Ca Levels Less Than 8.0 mg/dL (2.0 mmol/L)
To characterize the safety of etelcalcetide treatment based on laboratory values.
Measured: During the treatment period (up to 31 weeks)
Proportion of Participants with Hypocalcemia
To characterize the safety of etelcalcetide treatment based on laboratory values.
Hypocalcemia is defined as corrected serum calcium levels less than 8.4 mg/dL.
Measured: During the treatment period (up to 31 weeks)
Etelcalcetide Plasma Concentrations Before and at the end of Dialysis After Single and Multiple Doses
Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses.
Measured: During the treatment period (up to 31 weeks)
Maximum-observed Concentration (Cmax) of Etelcalcetide
Etelcalcetide plasma concentrations before and at the end of dialysis after single and multiple doses.
Measured: During the treatment period (up to 31 weeks)
Plasma Trough Concentrations (Cmin) of Etelcalcetide
To characterize the PK of etelcalcetide treatment after single and multiple doses.
Measured: During the treatment period (up to 31 weeks)
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
To characterize the safety of etelcalcetide treatment based on adverse events. Nature, frequency, severity, and relationship to treatment of all adverse events, including those of special interest reported during the trial.
Measured: During the treatment period (up to 31 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start20 Dec 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will remain on treatment for 26 weeks from day 1 or until the time of renal transplant or parathyroidectomy, whichever occurs first. Participants will receive a starting dose of etelcalcetide 0.07 mg/kg or 5 mg, whichever is lower, 3 times a week (TIW) intravenously. The dose of etelcalcetide will be titrated every 4 weeks (weeks 5, 9, 13, and 17) based on intact parathyroid hormone (iPTH), calcium, and safety to a maximum dose of 0.21 mg/kg or 15 mg, whichever is lower. The lowest protocol specified dose (PSD) for this trial is 0.035 mg/kg or 2.5 mg, whichever is lower.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969329
- Sponsor's protocol ID
- 20170724
- Status last verified
- Aug 2026
- First submitted
- 29 May 2019
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT03969329
- Acronym / sponsor ID
- 20170724
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Secondary hyperparathyroidism (sHPT), Chronic kidney disease (CKD), Paediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will remain on treatment for 26 weeks from day 1 or until the time of renal transplant or parathyroidectomy, whichever occurs first. Participants will receive a starting dose of etelcalcetide 0.07 mg/kg or 5 mg, whichever is lower, 3 times a week (TIW) intravenously. The dose of etelcalcetide will be titrated every 4 weeks (weeks 5, 9, 13, and 17) based on intact parathyroid hormone (iPTH), calcium, and safety to a maximum dose of 0.21 mg/kg or 15 mg, whichever is lower. The lowest protocol specified dose (PSD) for this trial is 0.035 mg/kg or 2.5 mg, whichever is lower.
| Arm | Type | Receives |
|---|---|---|
| Etelcalcetide | Experimental | Drug: EtelcalcetideParticipants will receive etelcalcetide in addition to standard of care. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any trial-specific activities/procedures being initiated.
- Male or female participants greater than or equal to 2 to less than 18 years of age at the time of enrollment.
- Targeted dry weight greater than or equal to 7 kg at the time of screening Week -1.
- Diagnosed with CKD and SHPT undergoing hemodialysis/hemodiafiltration TIW or four times a week (QIW) at the time of screening greater than or equal to 1 month.
- Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values greater than 300 pg/mL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening.
Key exclusion criteria (35 listed)
- Disease Related:
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval.
- Anticipated or scheduled parathyroidectomy during the trial period.
- Anticipated or scheduled kidney transplant during the trial period.
- Participant has received a parathyroidectomy within 6 months prior to enrollment.
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: Parsabiv - brand nameEtelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, calcium (Ca), and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe. | Drug | Etelcalcetide |
Primary outcome
Percent Change From Baseline in iPTH at Weeks 20 to 26
Time frame: Week 20 to 26
To evaluate the efficacy of etelcalcetide in reducing the iPTH level in children ages equal to or greater than 2 to less than 18 years with SHPT receiving maintenance hemodialysis.
8 secondary outcomes
Number of Participants Who Achieve a >30% Reduction From Baseline in Mean iPTH
Time frame: Week 20 to 26
Percent Change From Baseline in Corrected Total Serum Ca and Serum Phosphorus
Time frame: Week 20 to 26
Proportion of Participants Achieving Corrected Serum Ca Levels Less Than 8.0 mg/dL (2.0 mmol/L)
Time frame: During the treatment period (up to 31 weeks)
Proportion of Participants with Hypocalcemia
Time frame: During the treatment period (up to 31 weeks)
Etelcalcetide Plasma Concentrations Before and at the end of Dialysis After Single and Multiple Doses
Time frame: During the treatment period (up to 31 weeks)
Maximum-observed Concentration (Cmax) of Etelcalcetide
Time frame: During the treatment period (up to 31 weeks)
Plasma Trough Concentrations (Cmin) of Etelcalcetide
Time frame: During the treatment period (up to 31 weeks)
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: During the treatment period (up to 31 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- 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
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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.
MD study director
Amgen
23 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etelcalcetide in people with Secondary Hyperparathyroidism, run by Amgen at 23 sites in 12 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 11 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, United Kingdom, France, Greece, Hungary and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in iPTH at Weeks 20 to 26 (time frame: Week 20 to 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.