Study to Evaluate Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease
Conditions
Chronic Kidney Disease - Hyperparathyroidism, Secondary - Secondary Hyperparathyroidism
Conditions: official terms
Hyperparathyroidism - Hyperparathyroidism, Secondary - Kidney Diseases - Neoplasm Metastasis - Renal Insufficiency, Chronic
Conditions: Keywords
pediatric, CKD, dialysis, paediatric
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cinacalcet HCl
Type: Drug
Overall Status
Recruiting
Summary
This is a single dose study of cinacalcet HCl conducted in pediatric subjects 28 days to < 6 years of age with chronic kidney disease receiving dialysis. The study is aimed at evaluating the safety and tolerability of cinacalcet HCl.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 2190 Days
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Subject's parent, or legally acceptable guardian, must sign an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form.

- Subjects 28 days to < 6 years of age with CKD and sHPT as diagnosed by principal investigators, undergoing hemodialysis or peritoneal dialysis at the time of screening (subjects 6 months or older should have been receiving dialysis for ≥ 1 months) and who have not received any cinacalcet HCl therapy for at least 2 weeks prior to dosing on Day 1

- Free of any disease or condition (other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject's safety or the integrity of the study data).

- Must weigh ≥ 6 kg at screening and at Day-1.

- Must be at least 30 weeks of gestational age.

- Physical examination must be acceptable to the investigator at screening and at Day -1.

- Hemoglobin ≥ 8 g/dL at screening and at Day -1.

- Serum calcium within age-appropriate normal ranges per NKF-K/DOQI guidelines at screening and at Day -1

- Normal or clinically acceptable ECG (12-lead reporting RR, PR, QRS, and QTc intervals) at screening and at Day -1.

- Clinical laboratory tests that are acceptable to the investigator at screening and at Day -1.

Exclusion Criteria

- Current or historic malignancy.

- Cardiac ventricular arrhythmias within 28 days prior to screening.

- A gastrointestinal disorder or surgery that could affect the absorption of drugs (eg, pyloric stenosis or any gut-shortening surgical procedure prior to screening).

- History of seizure.

- Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screening.

- 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.

- History of prolongation of the QT interval (eg, congenital long QT interval, second or third degree heart block or other conditions which prolong the QT interval)

- Corrected QT Interval (QTc) > 500 ms during screening, using Bazett's formula

- QTc ≥ 450 and ≤ 500 ms during screening, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist

- Known hypersensitivity to cinacalcet HCl or any of the excipients in cinacalcet HCl.

- Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketokonazole, itraconazole) within the 14 days prior to enrollment and during the study.

- Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (eg, flecainide, vinblastine, thioridazine, tricyclic antidepressants such as desipramine and imipramine, and beta-blockers such as metoprolol or carvedilol).

- Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin). Please refer to the complete QT prolongation medication list at http://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf

- Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(s).

- Other investigational procedures while participating in this study are excluded.
Locations
Research Site
Los Angeles, California, United States
Status: Recruiting
Research Site
Kansas City, Missouri, United States
Status: Recruiting
Research Site
Gent, Belgium
Status: Recruiting
Research Site
Leuven, Belgium
Status: Recruiting
Research Site
Heidelberg, Germany
Status: Recruiting
Research Site
Bristol, United Kingdom
Status: Completed
Research Site
Glasgow, United Kingdom
Status: Completed
Research Site
Leeds, United Kingdom
Status: Completed
Research Site
Manchester, United Kingdom
Status: Completed
Research Site
Nottingham, United Kingdom
Status: Completed
Start Date
November 2010
Completion Date
November 2015
Sponsors
Amgen
Source
Amgen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page