A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
- Conditions
- Secondary hyperparathyroidism (SHPT) in pediatric patients with chronic kidney disease (CKD) in hemodialysisMedDRA version: 20.0Level: PTClassification code: 10020708Term: Hyperparathyroidism secondary Class: 100000004860Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-506471-10-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, Subject receiving Ca supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per protocol, SHPT not due to vitamin D deficiency, per investigator assessment, Male or female subjects = 2 to < 18 years of age at the time of enrollment, Targeted dry weight = 7 kg at the time of screening Week -1, Diagnosed with CKD and SHPT undergoing hemodialysis/hemodiafiltration TIW at the time of screening = 1 month, Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values > 300 pg/mL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening, Serum cCa value =9.0 mg/dL obtained from the central laboratory during screening, Dialysate Ca level = 2.5 mEq/L for at least 1 month prior to screening and throughout the duration of the study, Subject receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol, Subject receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per protocol
History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia’s, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval, Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to enrollment that are not established therapies for subjects with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for subject participation. Paracetamol for analgesia will be allowed, Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded, Subject has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase [ALT] or serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST], or serum glutamic oxaloacetic transaminase [SGOT]) > 1.5 times the upper limit of normal (ULN), Corrected QT interval > 500 ms, using Bazett’s formula, Corrected QT interval = 450 to = 500 ms, using Bazett’s formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist, Subject has a clinically significant electrocardiogram (ECG) abnormality (eg,unstable arrhythmia) during screening that, in the opinion of the investigator,could pose a risk to subject safety or interfere with the study evaluation, New onset or worsening of a pre-existing seizure disorder, Subjects on anti-convulsant medication must be on a stable and therapeutic dose for 3 months prior to screening (if blood level monitoring is clinically available, then the subject must have a therapeutic blood level within 1 week of enrollment), Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product)., Female subjects of childbearing potential unwilling to use 1 highly effective or acceptable method of effective contraception during treatment and for an additional 3 months after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information, Anticipated or scheduled parathyroidectomy during the study period, Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test, Subject has known sensitivity to etelcalcetide or excipients to be administered during dosing, Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge, History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) or unacceptable physic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method