Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02909153 | Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis | PHASE1 | COMPLETED | 30 | — | — | Jan 1, 2017 | Jul 1, 2017 | Aug 8, 2019 | - | — |
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).
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).
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).
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).
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).
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).
| Arm | Type | Description |
|---|---|---|
| single dose of Triferic in the peritoneal dialysis solution | EXPERIMENTAL | The patient will receive a single dose of Triferic in the peritoneal dialysis solution (IP) during a long (12 hour) peritoneal dialysis dwell. Each Cohort will receive a different ascending IP dose ( 5 mg/L, 12.5 mg/L, 20 mg/L). Blood samples will be drawn periodically over a 12 hour period for analysis. |
| single IV dose of Triferic 6.6 mg over a 4 hour period | EXPERIMENTAL | The patient will receive a single 6.6 mg intravenous (IV) dose of Triferic in the over a 4 hour period. All Cohorts will receive the same IV dose. Blood samples will be drawn periodically over a 12 hour period for analysis. |
| Name | Type | Description |
|---|---|---|
| Triferic | DRUG | Triferic is an iron salt that is approved by the FDA for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients on chronic peritoneal dialysis. |
Inclusion Criteria: 1. The patient must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures. 2. The patient must be 18-75 years of age inclusive at the time of consent. 3. Have a diagnosi...