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Clinical Trials/EUCTR2011-004618-40-DE
EUCTR2011-004618-40-DEActive, not recruitingNot Applicable

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

Amgen Inc.0 sites20 target enrollmentStarted: February 27, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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, and not having received any cinacalcet therapy for at least 30 days prior to start of dosing
  • •Screening serum 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
  • •Normal or clinically acceptable ECG at screening (12-lead reporting with RR, PR, QRS, and QT intervals)
  • •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
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 20
  • •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 at screening or Day 1
  • •Congenital long QT interval, second or third degree heart block or other conditions which prolong the QT interval
  • •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
  • •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

Investigators

Sponsor
Amgen Inc.

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