Trial Outcomes & Findings for Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis (NCT NCT02909153)
NCT ID: NCT02909153
Last Updated: 2019-08-08
Results Overview
The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours
Results posted on
2019-08-08
Participant Flow
Participant milestones
| Measure |
Cohort 1
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Triferic in Dianeal PD Solution
|
6
|
6
|
6
|
0
|
0
|
|
Overall Study
Triferic 6.6mg Fe Via 4hr IV Infusions
|
6
|
5
|
6
|
6
|
6
|
|
Overall Study
Triferic in Extraneal PD Solution
|
0
|
0
|
0
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=6 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.2 • n=93 Participants
|
45.8 years
STANDARD_DEVIATION 19.6 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
45.2 years
STANDARD_DEVIATION 21.5 • n=483 Participants
|
56.3 years
STANDARD_DEVIATION 15.9 • n=36 Participants
|
53.3 years
STANDARD_DEVIATION 16.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
6 participants
n=483 Participants
|
6 participants
n=36 Participants
|
30 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hoursThe PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=6 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic
|
164 microgram per deciliter
Geometric Coefficient of Variation 25.0
|
213 microgram per deciliter
Geometric Coefficient of Variation 3.78
|
153 microgram per deciliter
Geometric Coefficient of Variation 32.1
|
163 microgram per deciliter
Geometric Coefficient of Variation 19.4
|
105 microgram per deciliter
Geometric Coefficient of Variation 15.9
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hoursThe PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=5 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic
|
1690 hours x micrograms/ deciliters
Geometric Coefficient of Variation 27.9
|
2220 hours x micrograms/ deciliters
Geometric Coefficient of Variation 9.84
|
2560 hours x micrograms/ deciliters
Geometric Coefficient of Variation 33.0
|
2510 hours x micrograms/ deciliters
Geometric Coefficient of Variation 41.8
|
2260 hours x micrograms/ deciliters
Geometric Coefficient of Variation 23.9
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hoursThe PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=5 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic
|
1690 hours x micrograms/ deciliters
Geometric Coefficient of Variation 27.9
|
2220 hours x micrograms/ deciliters
Geometric Coefficient of Variation 9.84
|
1580 hours x micrograms/ deciliters
Geometric Coefficient of Variation 41.8
|
1610 hours x micrograms/ deciliters
Geometric Coefficient of Variation 32.3
|
1050 hours x micrograms/ deciliters
Geometric Coefficient of Variation 20.9
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hoursThe PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=5 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic
|
217 micrograms/ deciliters
Geometric Coefficient of Variation 41.9
|
203 micrograms/ deciliters
Geometric Coefficient of Variation 32.6
|
183 micrograms/ deciliters
Geometric Coefficient of Variation 30.3
|
254212 micrograms/ deciliters
Geometric Coefficient of Variation 14.7
|
177 micrograms/ deciliters
Geometric Coefficient of Variation 30.8
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hoursThe PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=5 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic
|
1750 hours* micrograms/ deciliters
Geometric Coefficient of Variation 33.8
|
1730 hours* micrograms/ deciliters
Geometric Coefficient of Variation 28.2
|
2160 hours* micrograms/ deciliters
Geometric Coefficient of Variation 30.0
|
3060 hours* micrograms/ deciliters
Geometric Coefficient of Variation 33.6
|
2840 hours* micrograms/ deciliters
Geometric Coefficient of Variation 35.7
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hoursThe PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=5 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic
|
1750 hours* micrograms/ deciliters
Geometric Coefficient of Variation 33.8
|
1730 hours* micrograms/ deciliters
Geometric Coefficient of Variation 28.2
|
1530 hours* micrograms/ deciliters
Geometric Coefficient of Variation 41.3
|
1890 hours* micrograms/ deciliters
Geometric Coefficient of Variation 20.9
|
1560 hours* micrograms/ deciliters
Geometric Coefficient of Variation 31.7
|
SECONDARY outcome
Timeframe: 12 hoursThe bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 2
n=5 Participants
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 3
n=6 Participants
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 4
n=6 Participants
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
Cohort 5
n=6 Participants
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
|
|---|---|---|---|---|---|
|
Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax)
|
47.7 percent of bioavailability
Geometric Coefficient of Variation 28.3
|
26.5 percent of bioavailability
Geometric Coefficient of Variation 30.9
|
34.9 percent of bioavailability
Geometric Coefficient of Variation 25.2
|
62.6 percent of bioavailability
Geometric Coefficient of Variation 17.3
|
74.6 percent of bioavailability
Geometric Coefficient of Variation 25.9
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
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Cohort 2
n=6 participants at risk
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
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Cohort 3
n=6 participants at risk
Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
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Cohort 4
n=6 participants at risk
Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
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Cohort 5
n=6 participants at risk
Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose.
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|---|---|---|---|---|---|
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Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
16.7%
1/6 • Number of events 1 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
0.00%
0/6 • Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60