Safety and Tolerability of Cinacalcet in Pediatric Subjects With ChronicKidney Disease and Secondary Hyperparathyroidism

Conditions: Secondary hyperparathyroidism in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysis
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
MedDRA version: 18.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders

Registration Number: EUCTR2011-004618-40-Outside-EU/EEA

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 30

Inclusion Criteria

Subjects between the ages of 28 days to < 6 years of age, who have CKD and SHPT undergoing either HD or PD at the time of screening (subjects 6 months or older should have been receiving dialysis for = 1 month).
- Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
- Screening corrected total serum calcium from the central laboratory:
- = 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
- = 8.8 mg/dL (2.2 mmol/L) if age = 2 to < 6 years
- Serum phosphorus from the central laboratory:
- = 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
- = 4.5 mg/dL (1.13 mmol/L) if age = 1 to < 6 years
- SHPT not due to vitamin D deficiency, per investigator assessment
- Dry weight = 7 kg at the time of screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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 tachyarrhythmias or other conditions associated with prolonged QT interval
- Corrected QT interval (QTc) > 500 ms, using Bazett’s formula
- QTc =450 to = 500 ms, using Bazett’s formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize corrected serum calcium levels on treatment with cinacalcet in pediatric subjects with SHPT;Secondary Objective: - To characterize the pharmacokinetics (PK) in pediatric subjects<br>- To characterize the pharmacodynamics (PD) in pediatric subjects;Primary end point(s): Occurrence of corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for ages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages = 2 to < 6 years during the study;Timepoint(s) of evaluation of this end point: End of Study (The time when the last subject completes the last study<br>visit assessment)

Secondary Outcome Measures