Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SFP · 1 trial · 2 indications
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.
Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.
| Arm | Type | Description |
|---|---|---|
| SFP/Placebo | OTHER | Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks |
| Placebo/SFP | OTHER | Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks. |
| Name | Type | Description |
|---|---|---|
| SFP | DRUG | Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate |
| Placebo | OTHER | Dialysis with standard liquid bicarbonate concentrate without iron |
Parent Study, Double Blinded, Crossover: Key Inclusion Criteria: 1. Adult ≥ 18 years of age. 2. Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week. 3. Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL....
SFP, or soluble ferric pyrophosphate, is an investigational small molecule being studied for use in patients with End Stage Renal Disease who are receiving chronic hemodialysis. It is delivered through the dialysate to help manage iron levels in these patients.
SFP is a form of iron that is designed to deliver iron directly to the body during hemodialysis. By adding iron to the dialysate, it aims to maintain adequate iron levels in patients with End Stage Renal Disease who are undergoing chronic hemodialysis.
SFP is being developed by Rockwell Medical, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RMTI. The company is conducting clinical trials to evaluate the safety and efficacy of SFP in patients with End Stage Renal Disease.
SFP is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug remains investigational and has not been approved by regulatory authorities. It is still in clinical development for the treatment of End Stage Renal Disease.
SFP has one completed Phase 3 clinical trial, registered as NCT01503021. This study, titled 'Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis,' enrolled 718 participants with End Stage Renal Disease or Chronic Kidney Disease in the United States and Canada.
Yes, SFP is the same as soluble ferric pyrophosphate. The drug is commonly referred to by its abbreviation SFP in clinical trial documentation and by the developer, Rockwell Medical.