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 Bronx New York

Bronx, New York

from

Bronx, NY