Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ferric · 6 trials · 11 indications
Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).
Mean change from baseline was calculated separately for each treatment arm (LOCF)
The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
| Arm | Type | Description |
|---|---|---|
| Ferric Citrate | ACTIVE_COMPARATOR | Ferric citrate (FC) will be supplied as tablets containing 210mg of ferric iron (as 1g ferric citrate) to those subjects randomized to FC. These participants will be initiated on study drug with a fixed dose of FC beginning with 2 tablet per meal. |
| Standard of Care (SOC) | NO_INTERVENTION | Participants may receive open-label, non-FC phosphate binders at the discretion of their treating physician. During the Dialysis Period, dose of phosphate binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study. |
| KRX-0502 (ferric citrate) | EXPERIMENTAL | 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo |
| 1 g/day | EXPERIMENTAL | 1 g/day KRX-0502 (ferric citrate) |
| 6 g/day | EXPERIMENTAL | 6 g/day KRX-0502 (ferric citrate) |
| 8 g/day | EXPERIMENTAL | 8 g/day KRX-0502 (ferric citrate) |
| Name | Type | Description |
|---|---|---|
| Ferric Citrate | DRUG | Auryxia (ferric citrate) is a non calcium based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: 1. Age \>18 years at screening visit 2. Serum phosphate \> or equal to 3.0 mg/dL obtained at screening 3. CKD with eGFR \< or equal to 20 mL/min obtained at screening\* 4. Hemoglobin (Hgb) \>8.0 g/dL obtained at screening 5. TSAT \<55% obtained at screening 6. Females of child b...