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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03769441 | Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation | PHASE3 | COMPLETED | 148 | — | — | Aug 2, 2019 | Aug 19, 2024 | Aug 27, 2024 | 2 | Netherlands |
The between-group difference in change in exercise tolerance quantified by the six-minute walk test (6MWT)
| Arm | Type | Description |
|---|---|---|
| Ferric(III) carboxymaltose | ACTIVE_COMPARATOR | The intervention group will be treated with four dosages of 500 mg iron in the form of 10 mL ferric(III) carboxymaltose dissolved in 240 mL of NaCl 0.9%, with interval periods of six weeks. |
| Placebo | PLACEBO_COMPARATOR | The placebo-controlled group will receive four dosages of 250 mL of NaCl 0.9% solution with interval periods of six weeks. |
| Name | Type | Description |
|---|---|---|
| Ferric carboxymaltose | DRUG | Four intravenous dosages of ferric(III) carboxymaltose |
| Sodium chloride | DRUG | Four intravenous dosages of sodiumchloride |
Inclusion Criteria: * Kidney transplant recipient * Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20% * At least six months after transplantation at baseline * Age ≥18 years * Ability to comply with the study protocol * Informe...