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Also known as Ferric Citrate 1 GM Oral Tablet [AURYXIA]
Ferric 1 GM · 1 trial · 7 indications
Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality
| Arm | Type | Description |
|---|---|---|
| Ferric citrate | EXPERIMENTAL | Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks. |
| Placebo | PLACEBO_COMPARATOR | Tablets, matching in color and size to ferric citrate. |
| Name | Type | Description |
|---|---|---|
| Ferric Citrate 1 GM Oral Tablet [AURYXIA] | DRUG | All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed. |
| Placebo | DRUG | All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed. |
Inclusion Criteria: 1. Adult patients greater or equal to 18 years old. 2. Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as at least one local laboratory determined estimated glomerular filtration rate (eGFR) ≤20 ml/min/1.73m2 (calculated per any commonly used metho...
Ferric 1 GM is an oral ferric citrate tablet being studied for anemia and iron deficiency in adults with advanced chronic kidney disease. It is also known as Ferric Citrate 1 GM Oral Tablet [AURYXIA] and is being developed by Akebia Therapeutics, Inc. (AKBA).
Ferric 1 GM is developed by Akebia Therapeutics, Inc., which trades under the ticker AKBA. The company is responsible for the clinical development of this oral ferric citrate tablet.
Ferric 1 GM is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for the studied indications. The Phase 3 trial has been completed.
Ferric 1 GM has been evaluated in one completed Phase 3 clinical trial, NCT05085275, titled "Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease." The trial enrolled 289 participants and was conducted in the United States.
Yes, Ferric 1 GM is also known as Ferric Citrate 1 GM Oral Tablet [AURYXIA]. These names refer to the same oral ferric citrate product developed by Akebia Therapeutics, Inc. (AKBA) for anemia and iron deficiency in chronic kidney disease.