Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for the treatment of anemia and iron deficiency. It is being investigated in patients with advanced chronic kidney disease, where it may also address hyperphosphatemia and renal anemia. The drug is currently in Phase 3 clinical development.
Ferric 1 GM is a small molecule that provides iron, which is essential for red blood cell production. By delivering iron, it helps correct iron deficiency and anemia. It is being studied in patients with chronic kidney disease who often have both anemia and iron deficiency.
Ferric 1 GM is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company. Akebia Therapeutics is publicly traded under the ticker symbol AKBA on the stock market.
Ferric 1 GM is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, involving 289 participants.
Ferric 1 GM has one completed Phase 3 clinical trial, identified as NCT05085275. The trial was a randomized, double-blind, placebo-controlled study titled 'Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease.' It enrolled 289 participants in the United States.
Ferric 1 GM is a formulation of ferric citrate, as indicated by the clinical trial title. The trial evaluates ferric citrate for the prevention of renal failure in adults with advanced chronic kidney disease. Ferric citrate is a form of iron used to treat anemia and iron deficiency.