Brief Summary
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
Brief Title
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
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 enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.
Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.
Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Kidney Disease
Hyperparathyroidism, Secondary
Eligibility Criteria
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)
* 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)
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Keywords
Dialysis
Sensipar
Mimpara
Hemodialysis
Peritoneal Dialysis
Renal
Parathyroid hormone
Pediatric
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
2189 Days
Minimum Age
28 Days
NCT Id
NCT01439867
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20110100
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
Primary Outcomes
Outcome Description
Hypocalcemia was defined as corrected serum calcium levels \< 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to \< 2 years, and \< 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to \< 6 years at any time during the study.
Outcome Measure
Percentage of Participants With Hypocalcemia
Outcome Time Frame
26 weeks
Secondary Ids
Secondary Id
2011-004618-40
Secondary Outcomes
Outcome Time Frame
26 weeks
Outcome Measure
Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Outcome Time Frame
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Outcome Measure
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Outcome Time Frame
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Outcome Measure
Percent Change From Baseline in Corrected Serum Calcium
Outcome Time Frame
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Outcome Measure
Percent Change From Baseline in Serum Phosphorous
Outcome Time Frame
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Outcome Measure
Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Outcome Description
A participant was considered to have achieved \> 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were \< -30% regardless if there was a missing value in between.
Outcome Time Frame
26 weeks
Outcome Measure
Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
Outcome Description
A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.
Outcome Time Frame
26 weeks
Outcome Measure
Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study
Outcome Description
A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.
Outcome Time Frame
26 weeks
Outcome Measure
Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
Outcome Description
A participant was considered to have achieved iPTH \< 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was \< 300 pg/mL.
Outcome Time Frame
26 weeks
Outcome Measure
Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
Outcome Time Frame
Week 12
Outcome Measure
Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Outcome Time Frame
Week 12
Outcome Measure
Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
5
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anna Zolotnitskaya
Investigator Email
azolotni@montefiore.org
Investigator Phone