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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00994318 | Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) | PHASE3 | COMPLETED | 626 | — | — | Dec 1, 2009 | Feb 1, 2014 | May 20, 2014 | 19 | United States, Australia +17 |
Endpoint reported number of participants with/without events and was reached: * First time of initiation of additional or alternative anaemia management, * First time the subject reached the Hb trigger. 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order: 1. FCM (high ferritin target) compared with oral iron. 2. FCM (high ferritin target) compared with FCM (low ferritin target). 3. FCM (low ferritin target) compared with oral iron. Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management: 1. Without taking into account the Hb trigger. 2. Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data. 3. Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.
| Arm | Type | Description |
|---|---|---|
| FCM (high ferritin target) | EXPERIMENTAL | Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L |
| FCM (low ferritin target) | EXPERIMENTAL | Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L |
| Oral Iron | ACTIVE_COMPARATOR | Ferrous sulphate 100 mg iron twice daily, continuous |
| Name | Type | Description |
|---|---|---|
| FCM (Ferric carboxymaltose) high ferritin target | DRUG | - |
| FCM (Ferric carboxymaltose) low ferritin target | DRUG | - |
| Oral Iron (Ferrous sulphate) | DRUG | - |
Inclusion Criteria: 1. At least 18 years of age. 2. NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m2 using modification of diet in renal disease 4 (MDRD-4) calculation. 3. NDD-CKD subjects with an eGFR loss ≤12 mL/min/1.73 m2/year and a predicted eGFR of ≥15 m...