A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparat… (NCT02833857) | Clinical Trial Compass
CompletedPhase 1
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
United States, Belgium, Germany11 participantsStarted 2017-03-14
Plain-language 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.
Who can participate
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Common Treatment-emergent Adverse Events
Timeframe: 30 days
2
Change From Baseline in Serum Corrected Calcium Concentration Over Time
Timeframe: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
3
Change From Baseline in Serum Phosphorus Concentration at End of Study
Timeframe: Baseline and day 30 (end of study)
4
Change From Baseline in Serum Potassium Concentration at End of Study
Timeframe: Baseline and day 30 (end of study)
5
Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
Timeframe: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
6
Change From Baseline in Heart Rate at End of Study
Timeframe: Baseline and day 30 (end of study)
7
Change From Baseline in Temperature at End of Study