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Clinical Trial Details

Trial ID: L0852
Source ID: NCT02739100
Associated Drug: Triferic
Title: Pharmacokinetics and Preliminary Bioequivalence 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/NCT02739100/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, 4, 5, 6, 8, 10, and 12 hours|Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last))., The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session., 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours | Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Safety will be documented by recording the incidence of treatment-emergent adverse events (TEAEs), 13 days|Number of Participants With Treatment-emergent Serious Adverse Events (TEAEs), Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs), 13 days
Sponsor/Collaborators: Sponsor: Rockwell Medical Technologies, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-04
Completion Date: 2016-07
Results First Posted: 2019-02-01
Last Update Posted: 2019-02-01
Locations: Orlando Clinical Research Center, Orlando, Florida, 32809, United States
URL: https://clinicaltrials.gov/show/NCT02739100