Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis MedDRA version: 20.0 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 101 Subject’s legally acceptable representative has provided 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. 102 Male or female subjects (aged 2 to less than 18 years) diagnosed with CKD and sHPT and receiving maintenance haemodialysis or haemodiafiltration for > 30 days prior to screening. 103 Subject must be on a dialysate calcium concentration of = 2.5 mEq/L (1.25 mmol/L) for at least 1 month prior to enrollment and throughout the duration of the study. 104 Screening and Baseline serum PTH level > 200 pg/mL (21 pmol/L). 105 Subject must weigh = 7 kg at Baseline (Day -2). 106 Screening and Baseline serum corrected calcium from the local laboratory = 9 mg/dL (2.25 mmol/L). 107 Subjects on anti-convulsant medication must be on a stable dose for 3 months. 108 Free of any disease or condition other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject’s safety or the integrity of the study data. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 201 Currently receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of etelcalcetide. Other investigational procedures while participating in this study are excluded. 202 Subject previously has entered this study or previously exposed to etelcalcetide. 203 All herbal medicines (eg, St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of etelcalcetide, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of this review and Amgen acknowledgment is required for subject participation. 204 Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to receiving the first dose of etelcalcetide 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 this review and Amgen acknowledgment is required for subject participation. Paracetamol (up to 2 g per day) for analgesia will be allowed. 205 Malignancy except non-melanoma skin cancers,within the last 5 years. 206 History of hypersensitivity or allergic reaction to any of the excipients listed in Section 6.2.1. (protocol) 207 Subject received cinacalcet therapy within less than 30 days prior to etelcalcetide dosing. 208 A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to etelcalcetide administration. 209 Subject’s screening 12-lead ECG suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator’s opinion. 210 History of prolongation of the QT interval (eg, congenital long QT interval, second or third degree heart block or other conditions which prolong the QT interval) or history of ventricular arrhythmias. 211 Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin). Please refer to the complete QT prolongation medication list at http://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf 212 Subjects with a corrected QT Interval (QTc) > 500 ms during screening, using Bazett’s formula. 213 Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes. 214 Subject has a screening ALT or AST from the local lab = 1.5 times the upper limit of normal (ULN). 215 Female subjects of childbearing potential who are unwilling to practice true sexual abstinence or use an acceptable method(s) of effective birth control during treatment through 3 months after receiving the etelcalcetide. 216 Post-menarchal subject who is pregnant or breastfeeding, or is planning to become pregnant or breastfeed during treatment and for an additiona
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of etelcalcetide after single dose administration to paediatric subjects aged 2 to less than 18 years with secondary hyperparathyroidism (sHPT) receiving maintenance haemodialysis;Secondary Objective: To evaluate the pharmacokinetic profile of plasma etelcalcetide, serum PTH and serum calcium (total calcium, ionized calcium and albumin corrected calcium) levels following single intravenous (IV) administration of etelcalcetide.;Timepoint(s) of evaluation of this end point: Day 1-30; Primary end point(s): • Common treatment-emergent adverse events [including changes in physical examinations] • Changes in key laboratory safety tests [albumin corrected calcium (cCalcium), phosphorus, potassium, parathyroid hormone (PTH)], ECGs and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pharmacokinetic parameters (AUC, Cmax, tmax, t1/2) of etelcalcetide in plasma • Pharmacodynamics: concentration of parathyroid hormone (PTH), serum calcium [total calcium, ionized calcium and albumin corrected calcium] over time • Anti-etelcalcetide antibodies • Incidence of treatment-emergent adverse events ;Timepoint(s) of evaluation of this end point: Day 1-30 | — |
Countries
Belgium, Czech Republic, France, Germany, Lithuania, Poland, United Kingdom, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed