Trial Outcomes & Findings for Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients (NCT NCT03303144)
NCT ID: NCT03303144
Last Updated: 2020-11-16
Results Overview
The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours
Results posted on
2020-11-16
Participant Flow
All 27 participants in the study were randomly assigned to cross-over between the three treatments on Day 3, Day 8 and Day 10.
Participant milestones
| Measure |
Triferic Via Hemodialysate (Day 3)
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
|
Triferic Via IV Infusion( Pre-dialyzer) (Day 8)
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)
|
Triferic Via IV Infusion (Post-dialyzer) (Day 10)
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
|
|---|---|---|---|
|
Triferic Via IV Infusion (Day 8)
COMPLETED
|
0
|
25
|
0
|
|
Triferic Via IV Infusion (Day 8)
NOT COMPLETED
|
0
|
1
|
0
|
|
Triferic Via IV Infusion (Day 10)
STARTED
|
0
|
0
|
26
|
|
Triferic Via IV Infusion (Day 10)
COMPLETED
|
0
|
0
|
25
|
|
Triferic Via IV Infusion (Day 10)
NOT COMPLETED
|
0
|
0
|
1
|
|
Triferic Via Hemodialysate (Day 3)
STARTED
|
26
|
0
|
0
|
|
Triferic Via Hemodialysate (Day 3)
COMPLETED
|
26
|
0
|
0
|
|
Triferic Via Hemodialysate (Day 3)
NOT COMPLETED
|
0
|
0
|
0
|
|
Triferic Via IV Infusion (Day 8)
STARTED
|
0
|
26
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Baseline characteristics by cohort
| Measure |
Safety Population
n=27 Participants
All patients in study
|
|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hoursThe PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.
Outcome measures
| Measure |
Triferic Via Hemodialysate
n=25 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion (Post-dialyzer)
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Triferic: ferric pyrophosphate citrate
|
Triferic Via Hemodialysate
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
|
|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax.
|
207 h*ug/dL
Geometric Coefficient of Variation 30.4
|
—
|
—
|
PRIMARY outcome
Timeframe: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hoursOutcome measures
| Measure |
Triferic Via Hemodialysate
n=26 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion (Post-dialyzer)
n=25 Participants
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Triferic: ferric pyrophosphate citrate
|
Triferic Via Hemodialysate
n=25 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
|
|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients:Cmax
|
215 h*ug/dL
Geometric Coefficient of Variation 21.6
|
195 h*ug/dL
Geometric Coefficient of Variation 25.6
|
207 h*ug/dL
Geometric Coefficient of Variation 30.4
|
PRIMARY outcome
Timeframe: 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hoursThe PK will be done by assessing the mean AUC(0-end) of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.5 mg iron/kg during a single dialysis session.
Outcome measures
| Measure |
Triferic Via Hemodialysate
n=26 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion (Post-dialyzer)
n=25 Participants
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Triferic: ferric pyrophosphate citrate
|
Triferic Via Hemodialysate
n=25 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
|
|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end).
|
1540 h*ug/dL
Geometric Coefficient of Variation 28.5
|
1450 h*ug/dL
Geometric Coefficient of Variation 31.4
|
1500 h*ug/dL
Geometric Coefficient of Variation 31.7
|
SECONDARY outcome
Timeframe: From the start of the HD #1 through the end of study participation or 7 days after the last dose of Triferic, whichever is later, assessed up to 2 monthsSafety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs).The number of patients that experienced treatment emergent serious adverse events will be quantified. Please see the adverse event table for specifics.
Outcome measures
| Measure |
Triferic Via Hemodialysate
n=27 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion (Post-dialyzer)
n=27 Participants
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Triferic: ferric pyrophosphate citrate
|
Triferic Via Hemodialysate
n=27 Participants
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
|
|---|---|---|---|
|
Safety Endpoint: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Incidence of Treatment Emergent Serious Adverse Events
|
2 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Triferic Via Hemodialysate
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Triferic Via IV Infusion( Pre-dialyzer)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Triferic Via IV Infusion (Post-dialyzer)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triferic Via Hemodialysate
n=27 participants at risk
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion( Pre-dialyzer)
n=27 participants at risk
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion (Post-dialyzer)
n=27 participants at risk
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Triferic: ferric pyrophosphate citrate
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.7%
1/27 • Number of events 1 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
3.7%
1/27 • Number of events 1 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
3.7%
1/27 • Number of events 1 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
Other adverse events
| Measure |
Triferic Via Hemodialysate
n=27 participants at risk
Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic over 4 hrs at one hemodialysis session.
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion( Pre-dialyzer)
n=27 participants at risk
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via arterial blood line (pre-dialyzer)
Triferic: ferric pyrophosphate citrate
|
Triferic Via IV Infusion (Post-dialyzer)
n=27 participants at risk
Patients will receive a single 6.5-mg dose of Triferic iron administered IV over 3 hrs during hemodialysis via venous blood line (post-dialyzer)
Triferic: ferric pyrophosphate citrate
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.7%
1/27 • Number of events 1 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
0.00%
0/27 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
3.7%
1/27 • Number of events 1 • Adverse events will be recorded on the AE CRF from the start of HD #1 (Day 1) through the end of study participation or 7 days after the last dose of Triferic (Day 10).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60