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 States56 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 range0 Years – 18 Years
SexALL
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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…
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