Trial Outcomes & Findings for A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients (NCT NCT04042324)

NCT ID: NCT04042324

Last Updated: 2020-12-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2020-12-02

Participant Flow

All twelve participants enrolled in the study were randomly assigned to cross-over between the three treatments on Days 1, 3 and 5.

Participant milestones

Measure	UFH and Triferic Admixture (Day 1) Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.	Triferic Post-dialyzer; UFH Via Continuous Infusion (Day 3) Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.	UFH Via Continuous Infusion Pre-dialyzer (Day 5) Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis
UFH and Triferic Admixture (Day 1) STARTED	12	0	0
UFH and Triferic Admixture (Day 1) COMPLETED	12	0	0
UFH and Triferic Admixture (Day 1) NOT COMPLETED	0	0	0
Triferic Post-dialyzer (Day 3) STARTED	0	12	0
Triferic Post-dialyzer (Day 3) COMPLETED	0	12	0
Triferic Post-dialyzer (Day 3) NOT COMPLETED	0	0	0
Triferic Pre-dialyzer (Day 5) STARTED	0	0	12
Triferic Pre-dialyzer (Day 5) COMPLETED	0	0	12
Triferic Pre-dialyzer (Day 5) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

Baseline characteristics by cohort

Measure	Safety Population n=12 Participants All patients enrolled in the study.
Age, Continuous	57.0 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 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	11 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Outcome measures

Measure	UFH and Triferic Admixture n=12 Participants Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t	.798 IU*hr/mL Geometric Coefficient of Variation 61.6	.733 IU*hr/mL Geometric Coefficient of Variation 62.4	—

SECONDARY outcome

Timeframe: 4 hours

Outcome measures

Measure	UFH and Triferic Admixture n=12 Participants Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours	.581 IU*hr/mL Geometric Coefficient of Variation 75.7	.600 IU*hr/mL Geometric Coefficient of Variation 77.9	.538 IU*hr/mL Geometric Coefficient of Variation 81.0

SECONDARY outcome

Timeframe: 4 hours

Outcome measures

Measure	UFH and Triferic Admixture n=12 Participants Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours	188 IU*hr/mL Geometric Coefficient of Variation 37.7	196 IU*hr/mL Geometric Coefficient of Variation 38.5	188 IU*hr/mL Geometric Coefficient of Variation 39.8

SECONDARY outcome

Timeframe: 4 hours

Outcome measures

Measure	UFH and Triferic Admixture n=12 Participants Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours	97.6 IU*hr/mL Geometric Coefficient of Variation 31.6	98.0 IU*hr/mL Geometric Coefficient of Variation 34.6	104 IU*hr/mL Geometric Coefficient of Variation 40.1

SECONDARY outcome

Timeframe: 8 hours

Outcome measures

Measure	UFH and Triferic Admixture n=12 Participants Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)	180 ug/dL Geometric Coefficient of Variation 20.9	174 ug/dL Geometric Coefficient of Variation 31.5	—

SECONDARY outcome

Timeframe: 8 hours

Outcome measures

Measure	UFH and Triferic Admixture n=12 Participants Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer n=12 Participants Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	UFH Via Continuous Infusion Pre-dialyzer Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t	1040 h*ug/dL Geometric Coefficient of Variation 31.1	1050 h*ug/dL Geometric Coefficient of Variation 43.4	—

Adverse Events

Triferic Post-dialyzer; UFH Via Continuous Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UFH and Triferic Admixture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UFH Via Continuous Infusion Pre-dialyzer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Pratt, MD

Rockwell Medical, Inc

Phone: 248 960 9009

Email: rpratt@rockwellmed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60