The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Single, oral dose of 0.25 mg/kg cinacalcet
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Louisville, Kentucky, United States
Research Site
Kansas City, Missouri, United States
Number of Participants With Adverse Events
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.
Time frame: Day 1 to day 30
Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Cinacalcet
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Terminal Half-life of Cinacalcet
The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.
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Research Site
Heidelberg, Germany
Research Site
Bristol, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Nottingham, United Kingdom
Time frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Percent Change From Baseline in Intact Parathyroid Hormone
Time frame: Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Total Calcium
Time frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Albumin Corrected Calcium
Time frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Ionized Calcium
Time frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.