Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina

Conditions
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Iron Deficiency, Anaemia

Intervention / Treatment
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* Drug: intravenous ferric carboxymaltose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Creatinine clearance ≤40 mL/min Hemoglobin 110-120 g/L Serum ferritin <100 µg/L or transferrin saturation <20% Monthly treatment with ESA and oral iron for at least six months before enrolment Exclusion Criteria: Other obvious cause of acute or chronic anemia than iron deficiency Expectation to require hemodialysis within the next six months Short life expectancy (<1 year) Pregnancy Decompensated heart failure History of allergic reactions to iron preparations and/or anaphylaxis from any cause Requirement of blood transfusions Chronic decompensated mental disorder or dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous ferric carboxymaltose<br> | Drug: intravenous ferric carboxymaltose<br>* 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%)<br>* Other names: Ferinject, Injectafer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, CKD, non-dialysis-dependent, ND-CKD, Erythropoiesis-stimulating agent, Ferric carboxymaltose, Iron