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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
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Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous ferric carboxymaltose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous ferric carboxymaltose | Drug | Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation >20%) |
| Measure | Description | Time Frame |
|---|---|---|
| ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anaemia and iron status | Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study | 6 months |
| Number of hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge E Toblli, Prof., MD | Hospital Aleman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Alemán | Buenos Aires | 1118 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25928811 | Derived | Toblli JE, Di Gennaro F. Switching patients with non-dialysis chronic kidney disease from oral iron to intravenous ferric carboxymaltose: effects on erythropoiesis-stimulating agent requirements, costs, hemoglobin and iron status. PLoS One. 2015 Apr 30;10(4):e0125528. doi: 10.1371/journal.pone.0125528. eCollection 2015. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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|
| 6 months |
| Number of transfusions | 6 months |
| Number of adverse reactions | 6 months |
| Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function | 6 months |
| Proteinuria at baseline and then bi-monthly until end of study as marker of renal function | 6 months |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |