Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

• Status: Terminated
• Trial end date: 2016-06-23
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Calcium, Dietary; Cinacalcet; Cinacalcet Hydrochloride; Ergocalciferols; Vitamin D; Vitamins

Criteria

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 cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)

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