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Clinical Trial Details

Trial ID: L0835
Source ID: NCT03303144
Associated Drug: Triferic
Title: Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03303144/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Triferic
Outcome Measures: Primary: Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax., 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., 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours|Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients:Cmax, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours|Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: AUC(0-end)., The 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., 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, and 12 hours | Secondary: Safety Endpoint: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Incidence of Treatment Emergent Serious Adverse Events, Safety 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., 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 months
Sponsor/Collaborators: Sponsor: Rockwell Medical Technologies, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-10-01
Completion Date: 2017-12-28
Results First Posted: 2020-11-16
Last Update Posted: 2020-11-16
Locations: Orlando Clinical Research Center, Orlando, Florida, 32809, United States
URL: https://clinicaltrials.gov/show/NCT03303144