Safety & Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease & Secondary Hyperparathyroidism
Conditions
Chronic Kidney Disease - Hyperparathyroidism, Secondary
Conditions: official terms
Hyperparathyroidism - Hyperparathyroidism, Secondary - Kidney Diseases - Neoplasm Metastasis - Renal Insufficiency, Chronic
Conditions: Keywords
Dialysis, Sensipar, Mimpara, Hemodialysis, Peritoneal Dialysis, Renal, Parathyroid hormone, Pediatric
Study Type
Interventional
Study Phase
Phase 2
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 multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain on study for 26 weeks or until time of kidney transplantation, whichever comes first. All subjects, in addition to receiving cinacalcet, will receive standard of care, which may include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 2189 Days
Minimum Age: N/A
Gender: Both
Criteria: Inclusion criteria:

- Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing

- Screening corrected total serum calcium from the central laboratory:

- 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years

- 8.8 (2.2 mmol/L) if age ≥ 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 to < 6 years

- SHPT not due to vitamin D deficiency, per investigator assessment

- Dry weight ≥ 7 kg at the time of screening

Exclusion criterion:

- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval

- Corrected QT interval (QTc) > 500 ms, using Bazett's formula

- QTc ≥450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)

- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Locations
Research Site
Birmingham, Alabama, United States
Status: Completed
Research Site
Little Rock, Arkansas, United States
Status: Completed
Research Site
Los Angeles, California, United States
Status: Recruiting
Research Site
Iowa City, Iowa, United States
Status: Recruiting
Research Site
Louisville, Kentucky, United States
Status: Recruiting
Research Site
Baltimore, Maryland, United States
Status: Recruiting
Research Site
Kansas City, Missouri, United States
Status: Recruiting
Research Site
St Louis, Missouri, United States
Status: Recruiting
Research Site
Greenville, North Carolina, United States
Status: Completed
Research Site
Cincinnati, Ohio, United States
Status: Recruiting
Research Site
Oklahoma City, Oklahoma, United States
Status: Recruiting
Research Site
Philadelphia, Pennsylvania, United States
Status: Recruiting
Research Site
Houston, Texas, United States
Status: Recruiting
Research Site
San Antonio, Texas, United States
Status: Recruiting
Research Site
Bruxelles, Belgium
Status: Recruiting
Research Site
Leuven, Belgium
Status: Recruiting
Research Site
Praha 5, Czech Republic
Status: Recruiting
Research Site
Bron cedex, France
Status: Recruiting
Research Site
Heidelberg, Germany
Status: Completed
Research Site
Budapest, Hungary
Status: Recruiting
Research Site
Debrecen, Hungary
Status: Completed
Research Site
Szeged, Hungary
Status: Recruiting
Research Site
Genova, Italy
Status: Recruiting
Research Site
Chihuahua, Mexico
Status: Completed
Research Site
Amsterdam, Netherlands
Status: Completed
Research Site
Grafton, Auckland, New Zealand
Status: Recruiting
Research Site
Gdansk, Poland
Status: Recruiting
Research Site
Krakow, Poland
Status: Recruiting
Research Site
Warszawa, Poland
Status: Recruiting
Research Site
Moscow, Russian Federation
Status: Recruiting
Research Site
Saint Petersburg, Russian Federation
Status: Recruiting
Research Site
Kosice, Slovakia
Status: Recruiting
Start Date
June 2012
Completion Date
April 2016
Sponsors
Amgen
Source
Amgen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page