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Erschienen in:
07.12.2018 | Correction
Correction to: An open-label, single-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cinacalcet in pediatric subjects aged 28 days to < 6 years with chronic kidney disease receiving dialysis
Erschienen in: Pediatric Nephrology | Ausgabe 4/2019
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Correction to: Pediatric Nephrology
Table 1
Inclusion and exclusion criteria
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Key inclusion criteria
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Age 28 days to < 6 years with CKD and sHPT, undergoing hemodialysis or peritoneal dialysis at screening (subjects ≥ 6 months should have been receiving dialysis for ≥ 1 month)
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Free of any disease or condition (other than those diseases or conditions related to their renal disease)
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Body weight ≥ 6 kg at screening and at day − 1; gestational age 30 weeks; physical examination must be acceptable to investigator at screening and at day − 1
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Serum calcium within age-appropriate normal ranges per NKF-K/DOQI guidelines at screening and at day − 1
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Hemoglobin ≥ 8 g/dL at screening and at day − 1
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Normal or clinically acceptable ECGs at screening and at day − 1
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Key exclusion criteria
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Current or historic malignancy
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Cardiac ventricular arrhythmias within 28 days prior to screening A gastrointestinal disorder or surgery that could affect drug absorption (e.g., pyloric stenosis or any gut-shortening surgical procedure prior to screening)
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A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to IP administration
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Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screening
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Received therapy with cinacalcet within 1 month prior to randomization Clinical lab signs of hepatic impairment
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Medications: use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketokonazole, itraconazole) within 14 days prior to enrollment and during study
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Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 with a narrow therapeutic index; use of medications that prolong QT interval
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Fig. 1
Study design and treatment schema. Screening was conducted between days − 21 to − 2. Subjects entered the clinical unit on day – 1 to undergo safety laboratory testing and baseline PD sampling and remained in residency until 24-h post-dose procedures were completed. Following pre-dose procedures and dosing on day 1, subjects underwent a 72-h period of PK, PD sampling, and safety monitoring. End of study procedures were conducted on day 4 (72 h post-dose). SAE follow-up was conducted to day 30. PD pharmacodynamic, PK pharmacokinetic. AE adverse evemt. SAE serious adverse event
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