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

Hospital Aleman

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency; Anaemia

Treatments: Drug: intravenous ferric carboxymaltose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02232906

FCM-ND-CKD 2012

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

intravenous ferric carboxymaltose

Experimental group

Treatment:

Drug: intravenous ferric carboxymaltose