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Clinical Trial Details

Trial ID: L1202
Source ID: NCT02909153
Associated Drug: Triferic
Title: Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02909153/results
Conditions: Peritoneal Dialysis (PD)|Anemia|Chronic Kidney Disease
Interventions: DRUG: Triferic
Outcome Measures: Primary: Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic, 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)., 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours|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, The 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)., 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours|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, The 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)., 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic, The 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)., 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours|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, The 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)., 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours|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, The 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)., 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours | Secondary: Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax), The bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts., 12 hours
Sponsor/Collaborators: Sponsor: Rockwell Medical Technologies, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-01
Completion Date: 2017-07
Results First Posted: 2019-08-08
Last Update Posted: 2019-08-08
Locations:
URL: https://clinicaltrials.gov/show/NCT02909153