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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Subjects between the ages of 28 days to < 6 years of age at enrollment
Diagnosed with CKD and SHPT undergoing either HD or PD at the time of screening (subjects 6 months or older should have been receiving dialysis for = 1 month)
Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory
Screening corrected calcium from the central laboratory:
- 9.4 mg/dL (2.35 mmol/L) for subjects aged 28 days to < 2 years
- 8.8 ( 2.2 mmol/L) for subjects aged 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 year to < 6 years
SHPT not due to vitamin D deficiency, per investigator assessment
Dialysate calcium level = 2.5 mEq/L during screening
Subjects on anti-convulsant medication must be on a stable dose and have a therapeutic blood level of the anti-convulsant at time of screening
Subject or subject's legally acceptable representative has provided informed consent, and subject has provided assent when required by institutional guidelines
Dry weight = 7 kg at the time of screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to first dose of IP
Received therapy with cinacalcet within 30 days prior to enrollment
Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely
Anemia which in the judgment of the investigator makes it inadvisable to undergo sequential blood draws
Subjects aged 28 days to 6 months of age who were born prematurely at < 36 weeks gestational age
Unstable chronic heart failure (CHF) defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening
History of congenital long QT interval, second or third degree heart block, ventricular tachyarrythmias or other conditions which prolong the QT interval
Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula, during screening
QTc > 450 to = 500 ms, using Bazett’s formula, during screening, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
Any evidence of active malignancy
Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening or enrollment
Any unstable medical condition or unacceptable physical findings which in the judgment of the investigator precludes enrollment in this study
Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase (AST) = 1.5 x upper limit of normal (ULN) OR alanine aminotransferase (ALT) = 1.5 x ULN OR total bilirubin = 1 x ULN per institutional laboratory range) at screening or Day 1
Known hypersensitivity to cinacalcet or any of the excipients in cinacalcet
Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) or, CYP2D6 substrates (e.g., flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) within the 14 days prior to enrollment and during the study
Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol), during screening
Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
Subject has previously been enrolled in this study
Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge
Subject or subject's guardian has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject or guardian to give written informed consent and/or to comply with all required study procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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