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.
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
27
sites
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