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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01286012 | Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients | PHASE2 | COMPLETED | 108 | — | — | Jan 1, 2011 | Jan 1, 2013 | Oct 1, 2018 | 23 | United States, Puerto Rico |
The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.
| Arm | Type | Description |
|---|---|---|
| SFP in liquid bicarbonate | ACTIVE_COMPARATOR | - |
| Placebo: Conventional Liquid Bicarbonate | PLACEBO_COMPARATOR | Control concentrate lacking SFP does not contain SFP (total iron = 0) |
| Name | Type | Description |
|---|---|---|
| Soluble Ferric Pyrophosphate in liquid bicarbonate | DRUG | Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks. |
| Placebo: Conventional liquid bicarbonate | DRUG | Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks. |
| Erythrocyte Stimulating Agent (ESA) | DRUG | ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change. |
| Intravenous (IV) Iron | DRUG | Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L. |
Main Inclusion Criteria: 1. Male and female subjects ≥ 18 years of age. 2. End-stage renal disease undergoing maintenance hemodialysis 3 to 4 times a week for at least 4 months and expected to remain on this schedule and be able to complete the study. Subjects on a cadaveric transplant list need no...