A Study to Assess the Efficacy and Safety of Cinacalcet in Pediatric Subjects With SHPT and CKD on Dialysis

Status:	Recruiting
Conditions:	Renal Impairment / Chronic Kidney Disease, Endocrine
Therapuetic Areas:	Endocrinology, Nephrology / Urology
Healthy:	No
Age Range:	6 - 17
Updated:	4/21/2016
Start Date:	November 2014
End Date:	December 2016
Contact:	Amgen Call Center
Phone:	866-572-6436

A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

This is a phase 3, 24-week, randomized, multicenter, open-label, controlled study. subjects
will be randomized into one of two treatment arms; oral administration of cinacalcet daily
in addition to standard of care treatment arm or a standard of care arm. Randomization will
be stratified by age group. All subjects receive standard of care which can include therapy
with Vitamin D sterols, calcium supplementation, and phosphate binders.

Inclusion Criteria:

- Age 6 - < 18 years

- Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values
≥ 300 pg/mL during screening

- Corrected calcium value of ≥ 8.8 mg/dL during screening

- Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days
prior to screening

- Parent or legally acceptable representative has provided written informed consent and
subject has provided written assent when required by institutional guidelines

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, or potent CYP 3A4 inhibitors (eg,
erythromycin, clarithromycin, ketoconazole, itraconazole)

- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron,
albuterol)

We found this trial at

sites

Clinical Trial Facility in Detroit Michigan

Detroit, Michigan

from

Detroit, MI