Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

• Status: Terminated
• Trial end date: 2016-06-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion criteria:

• Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)

• Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing

• Screening corrected calcium from the central laboratory:

• ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years

• ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years

• Serum phosphorus from the central laboratory:

• ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year

• ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years

• SHPT not due to vitamin D deficiency, per investigator assessment

• Dry weight ≥ 7 kg at the time of screening

Exclusion criterion:

• 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 (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)

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