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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with ≥ 30% reduction from baseline in intact parathyroid hormone (iPTH) level during the efficacy assessment phase (EAP)
Secondary outcome measures
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 moreSide effects data
From 2017 Phase 3 trial • 902 Patients • NCT0210220428%
Blood calcium decreased
10%
Diarrhoea
9%
Hyperphosphataemia
8%
Muscle spasms
7%
Nausea
7%
Upper respiratory tract infection
7%
Pain in extremity
7%
Hypertension
7%
Hypotension
6%
Vomiting
6%
Back pain
6%
Cough
6%
Dyspnoea
5%
Pneumonia
3%
Sepsis
3%
Arteriovenous fistula thrombosis
2%
Cardiac arrest
2%
Fluid overload
2%
Anaemia
2%
Atrial fibrillation
2%
Septic shock
2%
Hyperkalaemia
1%
Bronchitis
1%
Cholecystitis acute
1%
Urinary tract infection
1%
Cellulitis
1%
Asthenia
1%
Cardiac failure congestive
1%
Coronary artery disease
1%
Myocardial infarction
1%
Arthralgia
1%
Pulmonary oedema
1%
Osteomyelitis
1%
Chest pain
1%
Acute myocardial infarction
1%
Myocardial ischaemia
1%
Abdominal pain
1%
Gastrointestinal haemorrhage
1%
Lower gastrointestinal haemorrhage
1%
Pancreatitis acute
1%
Upper gastrointestinal haemorrhage
1%
Non-cardiac chest pain
1%
Pyrexia
1%
Device related infection
1%
Endocarditis
1%
Gangrene
1%
Gastroenteritis
1%
Mental status changes
1%
Peripheral ischaemia
1%
Respiratory tract infection
1%
Arteriovenous fistula site complication
1%
Arteriovenous graft thrombosis
1%
Fall
1%
Vascular access complication
1%
Cerebral haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Thrombosis in device
1%
Hypoxia
1%
Hypertensive crisis
1%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etelcalcetide
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
1,371 Previous Clinical Trials
1,378,081 Total Patients Enrolled
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,674 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your recent blood tests show high levels of certain liver enzymes, which may indicate liver problems.I have been taking cinacalcet for the last 30 days and will continue through the study.You have had high levels of calcium in your dialysis fluid for at least 4 weeks before screening and during the study.Your heart's QT interval is longer than 500 milliseconds when adjusted for your heart rate.Your heart's electrical activity (QTc) falls within a certain range, unless the doctor gets permission from a heart specialist.My baby was born prematurely and is now between 28 days and 6 months old.I am a woman able to have children and agree to use birth control during and for 3 months after treatment.I have a history of serious heart rhythm problems.I had surgery to remove my parathyroid gland within the last 6 months.I am not taking medications that affect heart rhythm.I have listed all herbal medicines, vitamins, and supplements I've taken in the last 30 days.I haven't taken any non-approved drugs for my kidney condition in the last 14 days or 5 half-lives.I am expecting to have a kidney transplant soon.I haven't had cancer, except for certain skin, cervical, or breast cancers, in the last 5 years.I am older than 28 days and younger than 18 years.My SHPT is not caused by a lack of vitamin D.My vitamin D, phosphate binder, or calcium supplement dose hasn't changed by more than 50% in the last 2 weeks.My lab tests show I have SHPT with high iPTH levels.My seizures have started or gotten worse in the last 60 days.I have been taking etelcalcetide for the last 6 months and will continue.I am scheduled for or might need a parathyroid gland surgery.I have chronic kidney disease and secondary hyperparathyroidism, and I am currently on hemodialysis.My blood calcium level is above the required minimum.I am not currently in another drug study and it's been over 30 days or 5 half-lives since my last one.My dry weight is at least 7 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Etelcalcetide
- Group 2: Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there specific demographic markers for the people who can join this research project?
"This study seeks to enroll 56 children and adolescents suffering from neoplasm metastasis. To be eligible, participants must also be within the following parameters: Anticipated or scheduled parathyroidectomy or kidney transplant during the study period., Dry weight ≥ 7 kg during screening., Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening., Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 400 pg/mL (42 pmol/L) during screening, on separate days and within 2 weeks of enrolment., Serum cCa value ≥ 9.0 mg/dL"
Answered by AI
Does this research include any participants above the age of 35?
"Children that meet the age requirements for this clinical trial (between 0 and 18 years old) are encouraged to participate in this research. Out of the 80 active clinical trials involving minors, 1122 are for seniors."
Answered by AI
Has Etelcalcetide received FDA approval for public use?
"There is both efficacy and safety data for Etelcalcetide at the Phase 3 level, so our team has rated it a 3."
Answered by AI
To your knowledge, does a similar trial exist?
"Amgen first sponsored a trial for etelcalcetide in 2019 and, after the successful completion of the 56-person study, the drug advanced to Phase 3 approval. Currently, there are 2 ongoing trials involving etelcalcetide being conducted in 21 cities and 22 countries."
Answered by AI
Are there several locations where this clinical trial is taking place?
"So far, 8 patients have enrolled in this clinical trial at locations including the Mount Sinai Kidney Center in New york, Children's Hospital of Philadelphia, and Children's Hospital of Los Angeles."
Answered by AI
Are there precedents for this medication in other areas of research?
"There are currently 2 clinical trials underway studying the efficacy of Etelcalcetide. Of those, 2 are in Phase 3. The majority of research locations for this medication are based in Cleveland, Ohio, but there are 59 sites in total running studies."
Answered by AI
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