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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02268994 | KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD | PHASE3 | COMPLETED | 234 | — | — | Oct 1, 2014 | Jan 1, 2016 | Mar 22, 2018 | 36 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| KRX-0502 (ferric citrate) | EXPERIMENTAL | 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| ferric citrate | DRUG | 1 g ferric citrate containing approximately 210 mg of ferric iron |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: 1. Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening 2. Age ≥18 years 3. CKD with Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDR...