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Also known as ferric citrate
ferric · 7 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).
Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.
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 |
| Active Control | ACTIVE_COMPARATOR | PhosLo (calcium acetate) Renvela (sevelamer carbonate) |
| 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 |
| ferric citrate, ca acetate, sevelamer carbonate, placebo | DRUG | All intervention doses will be based on serum phosphorus levels and/or drug label requirements |
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...
Ferric citrate is used to treat hyperphosphatemia and iron deficiency in people with chronic kidney disease, including those on dialysis and those not yet on dialysis. It is also studied for anemia of chronic kidney disease and end stage renal disease. It is a small molecule therapy developed by Akebia Therapeutics.
Ferric citrate is developed by Akebia Therapeutics, Inc., which trades on the Nasdaq under the ticker AKBA. Akebia has sponsored the clinical development program for ferric citrate across chronic kidney disease and end stage renal disease populations.
Ferric citrate is in Phase 3 clinical development. The program includes completed Phase 3 trials in chronic kidney disease and end stage renal disease, along with a completed Phase 2 trial in iron deficiency and iron deficiency anemia. All listed trials have been completed.
Ferric citrate has been studied in completed trials including NCT02492620 in CKD stage 4/5 transitioning to stage 5D, NCT02268994 in anemia of chronic kidney disease without dialysis, NCT01736397 in iron deficiency and anemia in CKD not on dialysis, and NCT01554982, a long-term safety extension in ESRD on dialysis.
Yes, ferric and ferric citrate refer to the same therapy. Ferric citrate is the full name of the small molecule developed by Akebia Therapeutics for hyperphosphatemia, iron deficiency, and anemia of chronic kidney disease. Searches for either name refer to the same clinical program.