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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01322347 | Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2) | PHASE3 | COMPLETED | 294 | — | — | Apr 1, 2011 | Feb 1, 2014 | Apr 26, 2017 | 40 | United States, Canada |
| NCT01320202 | Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients | PHASE3 | COMPLETED | 305 | — | — | Mar 1, 2011 | Nov 1, 2013 | Apr 26, 2017 | 47 | United States, Puerto Rico |
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).
| Arm | Type | Description |
|---|---|---|
| Soluble Ferric Pyrophosphate (SFP) in dialysate | ACTIVE_COMPARATOR | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. |
| Standard Dialysate | PLACEBO_COMPARATOR | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. |
| Name | Type | Description |
|---|---|---|
| Soluble Ferric Pyrophosphate (SFP) | DRUG | Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months. |
| Standard dialysate | DEVICE | Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week. |
Stage 1: Main Inclusion Criteria: * Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the stu...