Trial Outcomes & Findings for Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease (NCT NCT01290029)
NCT ID: NCT01290029
Last Updated: 2020-06-17
Results Overview
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.
COMPLETED
PHASE1
14 participants
Day 1 to day 30
2020-06-17
Participant Flow
The study was conducted at 7 study centers in Belgium (1 site), Germany (1 site), the United Kingdom (2 sites), and the United States (3 sites). The first participant was enrolled 25 January 2011 and the last participant on 25 August 2015.
Due to blood volume collection limitations in children, participants were randomized in a 1:1 ratio to one of the following 2 pharmacodynamic (PD) sampling sequences: 2, 8, and 48 hours postdose; or 2, 12, and 48 hours postdose.
Participant milestones
| Measure |
Cinacalcet 0.25 mg/kg
Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
Received Study Treatment
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Cinacalcet 0.25 mg/kg
Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Cinacalcet 0.25 mg/kg
n=14 Participants
Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Age, Continuous
|
39.5 months
STANDARD_DEVIATION 17.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 30Population: All participants who received at least 1 dose of cinacalcet.
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Number of Participants With Adverse Events
Any adverse event (AE)
|
3 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
0 participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of study drug
|
0 participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
1 participants
|
|
Number of Participants With Adverse Events
Adverse events of interest
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: Pharmacokinetics analysis set
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
|
11.8 hr*ng/mL
Standard Deviation 8.74
|
SECONDARY outcome
Timeframe: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=11 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet
|
11.3 hr*ng/mL
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: Pharmacokinetics analysis set
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Cinacalcet
|
2.83 ng/mL
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: Pharmacokinetics analysis set
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)
|
1.0 hours
Full Range 0.820 • Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dosePopulation: Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.
The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=11 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Terminal Half-life of Cinacalcet
|
3.70 hours
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.Population: Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Percent Change From Baseline in Intact Parathyroid Hormone
2 hours post-dose (n = 9)
|
-10.80 percent change
Interval -18.5 to 23.1
|
|
Percent Change From Baseline in Intact Parathyroid Hormone
8 hours post-dose (n = 5)
|
-29.6 percent change
Interval -42.2 to -12.6
|
|
Percent Change From Baseline in Intact Parathyroid Hormone
12 hours post-dose (n = 5)
|
29.40 percent change
Interval 27.7 to 31.2
|
|
Percent Change From Baseline in Intact Parathyroid Hormone
48 hours post-dose (n = 9)
|
-5.40 percent change
Interval -42.3 to 69.0
|
SECONDARY outcome
Timeframe: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.Population: Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Percent Change From Baseline in Total Calcium
2 hours post-dose (n = 11)
|
-4.33 percent change
Standard Deviation 6.82
|
|
Percent Change From Baseline in Total Calcium
8 hours post-dose (n = 5)
|
-6.38 percent change
Standard Deviation 5.12
|
|
Percent Change From Baseline in Total Calcium
12 hours post-dose (n = 6)
|
-6.63 percent change
Standard Deviation 5.05
|
|
Percent Change From Baseline in Total Calcium
48 hours post-dose (n = 8)
|
-4.54 percent change
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.Population: Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Percent Change From Baseline in Albumin Corrected Calcium
2 hours post-dose (n = 9)
|
-4.01 percent change
Standard Deviation 7.11
|
|
Percent Change From Baseline in Albumin Corrected Calcium
8 hours post-dose (n = 5)
|
-7.12 percent change
Standard Deviation 6.71
|
|
Percent Change From Baseline in Albumin Corrected Calcium
12 hours post-dose (n = 5)
|
-4.24 percent change
Standard Deviation 1.70
|
|
Percent Change From Baseline in Albumin Corrected Calcium
48 hours post-dose (n = 6)
|
-4.10 percent change
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.Population: Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.
Outcome measures
| Measure |
Cinacalcet 0.25 mg/kg
n=12 Participants
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Percent Change From Baseline in Ionized Calcium
12 hours post-dose (n = 4)
|
-4.15 percent change
Standard Deviation 10.12
|
|
Percent Change From Baseline in Ionized Calcium
48 hours post-dose (n = 6)
|
-1.45 percent change
Standard Deviation 4.80
|
|
Percent Change From Baseline in Ionized Calcium
2 hours post-dose (n = 9)
|
-1.77 percent change
Standard Deviation 3.55
|
|
Percent Change From Baseline in Ionized Calcium
8 hours post-dose (n = 4)
|
-4.20 percent change
Standard Deviation 3.83
|
Adverse Events
Cinacalcet 0.25 mg/kg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cinacalcet 0.25 mg/kg
n=12 participants at risk
Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • 30 Days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site haemorrhage
|
8.3%
1/12 • 30 Days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Device expulsion
|
8.3%
1/12 • 30 Days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Body temperature increased
|
8.3%
1/12 • 30 Days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • 30 Days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER