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

An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

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

This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.

The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.

Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).

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)