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Calcimimetic

Etelcalcetide for Secondary Hyperparathyroidism

Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 28 days or older and less than 18 years
SHPT not due to vitamin D deficiency, per investigator assessment
Must not have
Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization
Subjects aged 28 days to 6 months of age who were born prematurely at < 36 weeks gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-30 minutes post dose on day 1 and 10-30 minutes post dose on weeks 5, 9, 13, 17, and 21
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new drug to treat secondary hyperparathyroidism (a condition caused by kidney disease) in children.

Who is the study for?
This trial is for children under 18 with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), who are on hemodialysis. They must weigh at least 7 kg, have specific levels of parathyroid hormone and calcium, and not be due to vitamin D deficiency. Kids can't join if they've had certain cancers, used etelcalcetide recently, or are taking conflicting medications.
What is being tested?
The study tests Etelcalcetide's effectiveness in treating SHPT in kids with CKD on hemodialysis. It's a Phase 3 trial which means it’s closer to potentially being approved for general use if successful.
What are the potential side effects?
While the side effects aren't listed here, similar drugs often cause issues like low blood calcium levels, nausea, vomiting, muscle twitching or spasms. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 28 days and younger than 18 years.
Select...
My SHPT is not caused by a lack of vitamin D.
Select...
My vitamin D, phosphate binder, or calcium supplement dose hasn't changed by more than 50% in the last 2 weeks.
Select...
I have chronic kidney disease and secondary hyperparathyroidism, and I am currently on hemodialysis.
Select...
My blood calcium level is above the required minimum.
Select...
My dry weight is at least 7 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been taking cinacalcet for the last 30 days and will continue through the study.
Select...
My baby was born prematurely and is now between 28 days and 6 months old.
Select...
I have a history of serious heart rhythm problems.
Select...
I am expecting to have a kidney transplant soon.
Select...
I haven't had cancer, except for certain skin, cervical, or breast cancers, in the last 5 years.
Select...
I am scheduled for or might need a parathyroid gland surgery.
Select...
I am not currently in another drug study and it's been over 30 days or 5 half-lives since my last one.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-30 minutes post dose on day 1 and 10-30 minutes post dose on weeks 5, 9, 13, 17, and 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-30 minutes post dose on day 1 and 10-30 minutes post dose on weeks 5, 9, 13, 17, and 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with ≥ 30% reduction from baseline in intact parathyroid hormone (iPTH) level during the efficacy assessment phase (EAP)
Secondary study objectives
Achievement of ≥ 30% reduction in iPTH from baseline on two consecutive visits
Change from baseline in diastolic blood pressure
Change from baseline in heart rate
+15 more

Side effects data

From 2017 Phase 3 trial • 902 Patients • NCT02102204
28%
Blood calcium decreased
10%
Diarrhoea
9%
Hyperphosphataemia
8%
Muscle spasms
7%
Upper respiratory tract infection
7%
Nausea
7%
Pain in extremity
7%
Hypertension
7%
Hypotension
6%
Cough
6%
Dyspnoea
6%
Back pain
6%
Vomiting
5%
Pneumonia
3%
Sepsis
3%
Arteriovenous fistula thrombosis
2%
Hyperkalaemia
2%
Cardiac arrest
2%
Atrial fibrillation
2%
Septic shock
2%
Fluid overload
2%
Anaemia
1%
Arteriovenous graft thrombosis
1%
Gastrointestinal haemorrhage
1%
Non-cardiac chest pain
1%
Upper gastrointestinal haemorrhage
1%
Bronchitis
1%
Lower gastrointestinal haemorrhage
1%
Hypoxia
1%
Hypertensive crisis
1%
Gangrene
1%
Cholecystitis acute
1%
Gastroenteritis
1%
Asthenia
1%
Cellulitis
1%
Pyrexia
1%
Pancreatitis acute
1%
Arthralgia
1%
Syncope
1%
Myocardial ischaemia
1%
Fall
1%
Thrombosis in device
1%
Myocardial infarction
1%
Device related infection
1%
Cerebral haemorrhage
1%
Urinary tract infection
1%
Peripheral ischaemia
1%
Vascular access complication
1%
Respiratory tract infection
1%
Endocarditis
1%
Mental status changes
1%
Osteomyelitis
1%
Angina pectoris
1%
Coronary artery disease
1%
Pulmonary oedema
1%
Cerebrovascular accident
1%
Chest pain
1%
Arteriovenous fistula site complication
1%
Acute myocardial infarction
1%
Cardiac failure congestive
1%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etelcalcetide

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EtelcalcetideExperimental Treatment1 Intervention
Randomized in a 3:1 ratio to receive etelcalcetide in addition to standard of care
Group II: ControlActive Control1 Intervention
Randomized in a 3:1 ratio to receive etelcalcetide in addition standard of care alone (control arm)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etelcalcetide
2013
Completed Phase 3
~4590

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,458 Previous Clinical Trials
1,400,678 Total Patients Enrolled
MDStudy DirectorAmgen
995 Previous Clinical Trials
944,422 Total Patients Enrolled

Media Library

Etelcalcetide (Calcimimetic) Clinical Trial Eligibility Overview. Trial Name: NCT03633708 — Phase 3
Secondary Hyperparathyroidism Research Study Groups: Etelcalcetide, Control
Secondary Hyperparathyroidism Clinical Trial 2023: Etelcalcetide Highlights & Side Effects. Trial Name: NCT03633708 — Phase 3
Etelcalcetide (Calcimimetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03633708 — Phase 3
~9 spots leftby Jan 2026
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