Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

General (studies 20130356 and 20110100):

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(s), other than Amgen Studies 20130356 or 20110100.

Other investigational procedures while participating in this study are excluded.

Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.

Subject has known sensitivity to any of the products 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 (eg, electronic patient diary \[ediary\]) 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) 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.

If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment.

Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment

History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval

A new onset of seizures or worsening of pre-existing seizure disorder

Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening

Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159

Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely

Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening

Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase \[AST\] ≥ 1.5 × upper limit of normal \[ULN\] OR alanine aminotransferase \[ALT\] ≥ 1.5 × ULN OR total bilirubin ≥ 1 × ULN per institutional laboratory range) during screening

All Subjects - Day 1 Study Visit:

Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is ≥ Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator

Central laboratory values were not obtained/are not available at day 1 in Study 20140159

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)

What this study is about