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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02232906

Enrollment

Registered

2014-09-05

Start date

2011-03-31

Completion date

2013-09-30

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency, Anaemia

Keywords

Chronic kidney disease, CKD, non-dialysis-dependent, ND-CKD, Erythropoiesis-stimulating agent, Ferric carboxymaltose, Iron

Brief summary

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.

Interventions

DRUGintravenous ferric carboxymaltose

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%)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment	6 months

Secondary

Measure	Time frame	Description
Number of hospitalizations	6 months	—
Number of transfusions	6 months	—
Anaemia and iron status	6 months	Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study
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	—
Number of adverse reactions	6 months	—

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026