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Also known as ferric citrate, Ferric Citrate
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...
Ferric citrate is used to treat hyperphosphatemia and iron deficiency in people with chronic kidney disease, including end stage renal disease. It is studied in anemia of chronic kidney disease, iron deficiency, and iron deficiency anemia, and is developed by Akebia Therapeutics, Inc. (ticker AKBA).
Ferric citrate is developed by Akebia Therapeutics, Inc., which trades under the ticker AKBA. The company has sponsored Phase 2 and Phase 3 clinical trials of ferric citrate in chronic kidney disease, end stage renal disease, hyperphosphatemia, and iron deficiency anemia.
Ferric citrate is in Phase 3 clinical development. Its Phase 3 trials are completed, and it is investigational rather than approved. The program includes two completed Phase 3 studies plus a Phase 2 study, all conducted in the United States, with one Phase 3 trial also running in Puerto Rico.
Ferric citrate has been studied in completed trials including NCT02492620, a Phase 3 study of transition from CKD stage 4/5 to CKD stage 5D, and NCT02268994, a Phase 3 trial in anemia of chronic kidney disease. Other completed studies are NCT01736397 (Phase 2) and NCT01554982, a Phase 3 long-term safety extension in ESRD.
Yes. Ferric and ferric citrate refer to the same drug, and it is also written as Ferric Citrate. These names appear interchangeably in trial records and company materials for the Akebia Therapeutics (AKBA) development program in chronic kidney disease and related conditions.
The ferric citrate trials enrolled a total of 234 patients in the Phase 3 study NCT02268994, 200 in the Phase 3 study NCT02492620, 168 in the Phase 3 extension NCT01554982, and 149 in the Phase 2 study NCT01736397. The trials were randomized, double blind, and placebo controlled, and enrolled adults aged 18 years and older.