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

Stopped early · Phase 2

Conditions studied: Chronic Kidney Disease, Hyperparathyroidism, Secondary

In brief

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Key facts

Study ID

NCT01439867

Run by

Amgen

People needed

18

Starts

2012-06-22

Expected to finish

2016-06-03

Last updated by the study team

2020-06-17

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
• 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 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 (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
• Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Los Angeles, California, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — The Bronx, New York, United States
• Research Site — Greenville, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Brussels, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Prague, Czechia
• Research Site — Bron, France
• Research Site — Lille, France
• Research Site — Paris, France
• Research Site — Paris, France

Full record on ClinicalTrials.gov

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