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Clinical Trial Details

Trial ID: L0787
Source ID: NCT04689932
Associated Drug: Triferic Avnu
Title: Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04689932/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Triferic AVNU
Outcome Measures: Primary: Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer, The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours., On Days 1, 3, and 5, up to 3 hours|Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer, The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours., On Days 2, 4, and 6, up to 3 hours | Secondary: Mean TSAT Max Pre-Dialyzer, The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney, up to 3 hours|Mean TSAT Max Post-Dialyzer, The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney, up to 3 hours
Sponsor/Collaborators: Sponsor: Rockwell Medical Technologies, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-04-19
Completion Date: 2021-06-19
Results First Posted: 2022-01-18
Last Update Posted: 2022-02-28
Locations: Luxury Dialysis, Webster, Texas, 77598, United States
URL: https://clinicaltrials.gov/show/NCT04689932