A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic… (NCT03633708) | Clinical Trial Compass
RecruitingPhase 3
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
United States, Argentina, India56 participantsStarted 2019-04-29
Plain-language summary
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
Who can participate
Age range
0 Years – 18 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
* Age of 28 days \< 18 years.
* 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 ≥ 300 pg/mL (32 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
* Serum corrected calcium (cCa) value ≥ 9.0 mg/dL (2.25 mmol/L) for participants ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for participants 28 days to \< 2 years of age obtained from the central laboratory during screening.
* Dialysate Ca level ≥ 2.5 mEq/L during screening for at least 4 weeks prior to screening and throughout the duration of the trial.
* No more than a maximum prescribed dose change of 50% for active vitamin D sterols/phosphate binders/Ca supplements within the 2 weeks prior to screening assessments and remain stable.
* SHPT not due to vitamin D deficiency, per investigator assessment.
Exclusion Criteria Disease Related
* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's 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 randomization.
Other Medical Conditions
• History of other malignancy, except non-melanoma skin…
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
Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)
Timeframe: Baseline and Weeks 20-27
2
Percentage Change from Baseline in Mean iPTH During the EAP