Trial Outcomes & Findings for Triferic Pediatric Pharmacokinetic Protocol (NCT NCT02595437)
NCT ID: NCT02595437
Last Updated: 2018-10-25
Results Overview
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
COMPLETED
PHASE1/PHASE2
22 participants
0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs
2018-10-25
Participant Flow
Participant milestones
| Measure |
Triferic Via IV and Hemodialysate
Triferic was administered via IV infusion on study Day 1, and then mixed with the liquid bicarbonate and administered via hemodialysate on study Day 3.
|
|---|---|
|
Triferic Via IV
STARTED
|
22
|
|
Triferic Via IV
COMPLETED
|
21
|
|
Triferic Via IV
NOT COMPLETED
|
1
|
|
Triferic Via Hemodialysate
STARTED
|
21
|
|
Triferic Via Hemodialysate
COMPLETED
|
21
|
|
Triferic Via Hemodialysate
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Triferic Via IV and Hemodialysate
Triferic was administered via IV infusion on study Day 1, and then mixed with the liquid bicarbonate and administered via hemodialysate on study Day 3.
|
|---|---|
|
Triferic Via IV
Withdrawal by Subject
|
1
|
Baseline Characteristics
Triferic Pediatric Pharmacokinetic Protocol
Baseline characteristics by cohort
| Measure |
Safety Population
n=22 Participants
All patients enrolled in the study who received any amount of Triferic, regardless of whether the dose was administered intravenously or via dialysate.
|
|---|---|
|
Age, Continuous
|
11.8 years
STANDARD_DEVIATION 4.98 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrsPopulation: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.
|
217 microgram/deciliter
Geometric Coefficient of Variation 28.0
|
114 microgram/deciliter
Geometric Coefficient of Variation 53.7
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hoursPopulation: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).
|
1324 hours* micrograms/ deciliters
Geometric Coefficient of Variation 36.5
|
419 hours* micrograms/ deciliters
Geometric Coefficient of Variation 101.6
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hoursPopulation: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).
|
648 hours* micrograms/ deciliters
Geometric Coefficient of Variation 29.3
|
237 hours* micrograms/ deciliters
Geometric Coefficient of Variation 76.8
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hoursPopulation: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax.
|
261 micrograms/ deciliters
Geometric Coefficient of Variation 26.4
|
166 micrograms/ deciliters
Geometric Coefficient of Variation 54.3
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hoursPopulation: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron. The absolute AUC (last) includes the iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last).
|
1453 hours* micrograms/ deciliters
Geometric Coefficient of Variation 59.6
|
682 hours* micrograms/ deciliters
Geometric Coefficient of Variation 82.9
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hoursPopulation: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)
The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron. The absolute AUC (0-end) includes the of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end).
|
763 hours* micrograms/ deciliters
Geometric Coefficient of Variation 38.5
|
387 hours* micrograms/ deciliters
Geometric Coefficient of Variation 79.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1.5 weeksPopulation: Safety Population: all patients who received any amount of study medication are included in the safety population.
The incidence of treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs (TESAEs) will be grouped by body system. Adverse events were recorded from study Day 1 through the following up visit (approximately 1.5 weeks).
Outcome measures
| Measure |
Triferic 0.07 mg/kg Iron Intravenous: Absolute Value
n=22 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are the absolute values.
|
Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected
n=21 Participants
Patients were administered Triferic intravenously 0.07 mg/kg at the same time that they received their standard of care hemodialysis. The results for this group are baseline-corrected.
|
|---|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
|
4 Participants
|
3 Participants
|
Adverse Events
IV Exposure
IV and Hemodialysate Exposure
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Exposure
n=22 participants at risk
Patients in this population had received Triferic via IV infusion only at the time of onset of the adverse event.
|
IV and Hemodialysate Exposure
n=21 participants at risk
Patients in this population had received Triferic via IV infusion and via hemodialysate at the time of onset of the adverse event.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
0.00%
0/21 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
1/22 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
0.00%
0/21 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
0.00%
0/21 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
4.8%
1/21 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/22 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
4.8%
1/21 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
General disorders
Axillary Pain
|
0.00%
0/22 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
4.8%
1/21 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.5%
1/22 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
0.00%
0/21 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
0.00%
0/21 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.5%
1/22 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
0.00%
0/21 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
4.8%
1/21 • Number of events 1 • 1.5 weeks
Adverse events were collected from date of enrollment through the date of final study visit. The total time period of collection was approximately one and a half weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60