A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Phase 1

• Conditions: Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis; MedDRA version: 20.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-004608-21-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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 > = 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.

*Please, refers to procotol for the full list.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

- 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.
- Current malignancy or history of other malignancy, except nonmelanoma 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).

*Please, refers to protocol for the full list.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified