Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Soluble Ferric Pyrophosphate · 5 trials · 4 indications
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).
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
| 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. |
| 0 µg iron/dL of dialysate | PLACEBO_COMPARATOR | Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 5 µg iron/dL of dialysate | EXPERIMENTAL | 5 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 10 µg iron/dL of dialysate | EXPERIMENTAL | 10 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 12 µg iron/dL of dialysate | EXPERIMENTAL | 12 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| 15 µg iron/dL of dialysate | EXPERIMENTAL | 15 micrograms (µg) of iron/ deciliter (dL) of dialysate |
| Control | PLACEBO_COMPARATOR | Each subject will receive one control treatment and 5 treatments with SFP added to dialysate. The 5 SFP treatments will encompass 5 different conditions which may impact the intradialytic transfer of iron to the subject: new dialyzer, reused dialyzer, low blood/dialysate flow rate, low machine delivered bicarbonate concentration, and a different synthetic dialysis membrane (PAES). |
| Soluble Ferric Pyrophosphate | EXPERIMENTAL | Group/ cohort designation: Cellulose dialysis membrane (CT-190)/ Polyamide membrane. Each subject will receive one control treatment and 5 treatments with SFP added to dialysate. The 5 SFP treatments will encompass 5 different conditions which may impact the intradialytic transfer of iron to the subject: new dialyzer, reused dialyzer, low blood/dialysate flow rate, low machine delivered bicarbonate concentration, and a different synthetic dialysis membrane (PAES). |
| 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. |
| Standard Bicarbonate Solution | DEVICE | Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. |
| Soluble Ferric Pyrophosphate | DRUG | Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. |
| Placebo | OTHER | - |
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...
Soluble Ferric Pyrophosphate is an investigational small molecule being developed for patients with End-Stage Renal Disease (ESRD) and chronic kidney failure requiring hemodialysis. It is designed to deliver iron via dialysate during hemodialysis treatment. The drug is currently in clinical development and has not been approved by the FDA.
Soluble Ferric Pyrophosphate is being developed by Rockwell Medical, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol RMTI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in hemodialysis patients with chronic kidney failure.
Soluble Ferric Pyrophosphate has completed Phase 3 clinical trials, including two large studies with a combined enrollment of 599 patients. However, the drug remains investigational and is not yet FDA approved. It has also completed Phase 1 studies evaluating its pharmacokinetics and safety profile.
Soluble Ferric Pyrophosphate has completed two Phase 3 trials: NCT01320202 (CRUISE 1) with 305 patients and NCT01322347 (CRUISE 2) with 294 patients, both in chronic renal failure requiring hemodialysis. Additionally, two Phase 1 trials, NCT01894906 and NCT01920854, have been completed to assess iron transfer and dosing.
Soluble Ferric Pyrophosphate is designed to deliver iron directly through the dialysate during hemodialysis, bypassing the need for intravenous iron administration. This approach aims to maintain iron levels in patients with chronic kidney failure who are undergoing regular hemodialysis treatment.
Yes, Soluble Ferric Pyrophosphate is commonly referred to as SFP in clinical trial documentation. The trials NCT01320202 and NCT01322347 both describe the drug as 'Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate,' confirming that SFP is the abbreviated name for this investigational compound.