Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05085275 | Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease | PHASE3 | COMPLETED | 289 | — | — | Mar 30, 2022 | Jan 24, 2024 | Aug 29, 2025 | 23 | United States |
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...