Status:
TERMINATED
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
Lead Sponsor:
Amgen
Conditions:
Chronic Kidney Disease
Hyperparathyroidism, Secondary
Eligibility:
All Genders
28-2189 years
Phase:
PHASE2
Brief Summary
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Detailed Description
This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first. The study and en...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
June 22 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01439867
Start Date
June 22 2012
End Date
June 3 2016
Last Update
June 17 2020
Active Locations (42)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Little Rock, Arkansas, United States, 72202
3
Research Site
Los Angeles, California, United States, 90095
4
Research Site
Iowa City, Iowa, United States, 52242