A Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

  • STATUS
    Recruiting
  • End date
    Jun 29, 2022
  • participants needed
    20
  • sponsor
    Amgen
Updated on 12 August 2021
calcium
vitamin d
hemodiafiltration
chronic kidney disease
vitamin
renal disease
parathyroid hormone
active vitamin d
phosphate binder
ergocalciferol
secondary hyperparathyroidism
kidney disease
parathyroid hormones
parathyroid disorder
etelcalcetide

Summary

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

Details
Condition Hyperparathyroidism, Secondary hyperparathyroidism, Hyperparathyroidism (Pediatric)
Treatment Etelcalcetide
Clinical Study IdentifierNCT03969329
SponsorAmgen
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Male or female subjects greater than or equal to 2 to less than 18 years of age at the time of enrollment
Targeted Dry weight greater than or equal to 7 kg at the time of screening Week -1
Diagnosed with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) undergoing hemodialysis/hemodiafiltration three times per week (TIW) at the time of screening greater than or equal to 1 month
Diagnosis of secondary hyperparathyroidism (SHPT) with the mean of the 2 consecutive central laboratory intact parathyroid hormone (iPTH) values greater than 300 pg/mL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening
Serum corrected calcium (cCa) value greater than or equal to 9.0 mg/dL obtained from the central laboratory during screening
Dialysate calcium (Ca) level greater than or equal to 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
Subject receiving calcium (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
Secondary hyperparathyroidism (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, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval
Anticipated or scheduled parathyroidectomy during the study period
Anticipated or scheduled kidney transplant during the study period
Subject has received a parathyroidectomy within 6 months prior to enrollment
Other Medical Conditions
Current malignancy or history of other malignancy, except non-melanoma skin cancers within the last 5 years
Prior/Concomitant Therapy
Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance
Receipt of cinacalcet therapy within 30 days prior to screening and through enrollment
Any previous use of etelcalcetide prior to screening and through enrollment
All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the subject within the 30 days prior to enrollment, and continuing use if applicable, 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
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 (up to 2 g per day) for analgesia will be allowed
Prior/Concurrent Clinical Study Experience
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
Diagnostic Assessments During Screening
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]) greater than 1.5 times the upper limit of normal (ULN)
Corrected QT interval greater than 500 ms, using Bazett's formula
Corrected QT interval greater than or equal to 450 to less than or equal 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
Within the 3 Months Prior to Screening
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)
Other Exclusions
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 serum pregnancy test within 7 days prior to the first dose of investigational product)
Female subjects of childbearing potential unwilling to use 1 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
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 physical findings, that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation procedures or completion
Subject previously has entered this study or previously received treatment with etelcalcetide
Anemia, which in the opinion of the investigator makes it not advisable to undergo sequential blood draws
History of unstable chronic heart failure within the last 1 year prior to screening
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