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Calcimimetic

Etelcalcetide for Chronic Kidney Disease

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Serum Corrected Calcium Concentration Over Time
Common Treatment-emergent Adverse Events
Secondary study objectives
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
+4 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%
Back pain
6%
Cough
6%
Dyspnoea
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%
Bronchitis
1%
Vascular access complication
1%
Lower gastrointestinal haemorrhage
1%
Cholecystitis acute
1%
Hypoxia
1%
Hypertensive crisis
1%
Gastrointestinal haemorrhage
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%
Non-cardiac chest pain
1%
Respiratory tract infection
1%
Endocarditis
1%
Mental status changes
1%
Osteomyelitis
1%
Angina pectoris
1%
Coronary artery disease
1%
Pulmonary oedema
1%
Arteriovenous fistula site complication
1%
Arteriovenous graft thrombosis
1%
Cerebrovascular accident
1%
Gangrene
1%
Upper gastrointestinal haemorrhage
1%
Gastroenteritis
1%
Chest pain
1%
Acute myocardial infarction
1%
Cardiac failure congestive
1%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etelcalcetide

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EtelcalcetideExperimental Treatment1 Intervention
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etelcalcetide
FDA approved

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,439 Previous Clinical Trials
1,397,685 Total Patients Enrolled
MDStudy DirectorAmgen
977 Previous Clinical Trials
941,441 Total Patients Enrolled
~1 spots leftby Dec 2025
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