Cinacalcet Extension 20140159

Principal Investigator: Raoul  Nelson
Keywords: Cinacalecet , Kidney , Dialysis , Hyperparathyroidism Department: Pediatric Administration
IRB Number: 00083807 Co Investigator:  
Specialty: Pediatric Rheumatology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

JoAnn Narus
joann.narus@hsc.utah.edu
801-585-7497

Brief Summary

Primary

To characterize the long-term safety and tolerability of cinacalcet in pediatric subjects

with chronic kidney disease (CKD) receiving dialysis.

Secondary

To characterize the long-term effect of cinacalcet in pediatric subjects receiving dialysis

on laboratory parameters associated with chronic kidney disease – mineral and bone

disease (CKD-MBD).

Exploratory

To characterize the long-term effect of cinacalcet in pediatric subjects on linear and

pubertal growth.

 

 

Inclusion Criteria

Subjects from the cinacalcet arm of Study 20130356 or subjects in Study 20110100
who had their dose withheld at the EOIP visit, may enroll in this study if they meet
eligibility criteria but will not restart dosing until the criteria for restarting dosing, defined
in Section 6.2.3, are met.
Subjects who were ≤ 18 years old at week 20 in the 20130356 study or at the time of
study termination, are eligible to enter this Study 20140159 even if they have already
turned 18 years of age or are due to turn 18 years of age during their planned
participation in the 20140159 study.
 
Inclusion Criteria
1. 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 20140159 activities/procedures being initiated.
 
2. Dialysate calcium concentration ≥ 2.5 mEq/L at day 1
3. Subjects on anti-convulsant medication must be on a stable dose
All subjects with > 14 days between the last study visit in Study 20130356 or
Study 20110100 and screening for Study 20140159
4. Completed treatment through week 20 in the 20130356 study or on study at the
time of Study 20130356 termination
All subjects from 20130356
5. Dry weight ≥ 12.5 kg at day 1 of Study 20140159
6. iPTH value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159)
Subjects Randomized to the 20130356 Standard of Care Arm Only
7. Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159
All Subjects from 20110100
8. Completed week 26 End of Study visit in the, 20110100 study or on study at the
9. Dry weight ≥ 7 kg at day 1 of Study 20140159

 

Exclusion Criteria

4.1.2 Exclusion Criteria

General
Studies 20130356 or 20110100
 
201 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.
202 Other investigational procedures while participating in this study are excluded.
203 Malignancy except non-melanoma skin cancers, cervical or breast ductal
carcinoma in situ within the last 5 years.
204 Subject has known sensitivity to any of the products to be administered during
dosing.
205 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
206 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.
207 Subject previously has entered this study.
208 If sexually active, subject is not willing to use acceptable contraception during
treatment and for at least 9 days after the end of treatment.
209 Subject is pregnant or breast feeding, or planning to become pregnant during the
study or within 9 days after the end of treatment
210 History of congenital long QT syndrome, second or third degree heart block,
ventricular tachyarrythmias, or other conditions associated with prolonged QT
interval
211 A new onset of seizures or worsening of pre-existing seizure disorder
All Subjects with > 14 days between the last study visit in Study 20130356 or
Study 20110100 and the screening visit in Study 20140159 will have the following
exclusion criteria applied during screening and day 1:
212 Unstable chronic heart failure defined as worsening pulmonary edema or
other signs and symptoms as per investigator assessment during
screening
 
213 Received therapy with commercial cinacalcet after the last study visit in
Study 20130356 or Study 20110100 before day 1 of Study 20140159
214 Scheduled date for kidney transplantation from a known living donor that
makes completion of the study unlikely
215 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
216 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
217 Subject has an ongoing adverse event from Studies 20130356 or 20110100 that
is considered related to IP and:
• Is ≥ CTCAE (v 4.0) grade 3, and/or
• Considered clinically significant in the opinion of the investigator
218 Central laboratory values were not obtained/are not available at day 1 in
Study 20140159
219 Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula
220 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
221 Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin,
clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates
(eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline,
clomipramine)
222 Use of concomitant medications that may prolong the QTc interval
(eg, ondansetron, albuterol)