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Soluble Ferric Pyrophosphate in liquid bicarbonate · 1 trial · 1 indication
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...
Soluble Ferric Pyrophosphate in liquid bicarbonate is being developed for patients with End Stage Renal Disease. It is an investigational small molecule being studied as a means of delivering iron via dialysate during hemodialysis. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
Soluble Ferric Pyrophosphate in liquid bicarbonate is a small molecule that delivers iron directly through the dialysate during hemodialysis. By providing iron through this route, it aims to address iron deficiency in patients with End Stage Renal Disease who are undergoing hemodialysis treatment.
Soluble Ferric Pyrophosphate in liquid bicarbonate 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 this investigational drug for patients with End Stage Renal Disease.
Soluble Ferric Pyrophosphate in liquid bicarbonate is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of End Stage Renal Disease, with one completed Phase 2 trial involving 108 patients.
Soluble Ferric Pyrophosphate in liquid bicarbonate has one completed Phase 2 clinical trial, identified as NCT01286012, titled "Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients." This randomized, double-blind, placebo-controlled trial enrolled 108 patients with End Stage Renal Disease in the United States and Puerto Rico.
Yes, Soluble Ferric Pyrophosphate in liquid bicarbonate is also known as SFP, which stands for Soluble Ferric Pyrophosphate. The completed Phase 2 clinical trial NCT01286012 refers to the drug as SFP, and it is being studied for iron delivery via dialysate in hemodialysis patients with End Stage Renal Disease.