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

NCT ID: NCT02232906

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Iron Deficiency; Anaemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intravenous ferric carboxymaltose

Group Type: EXPERIMENTAL

intravenous ferric carboxymaltose

Intervention Type: 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%)

Interventions

intravenous 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%)

Intervention Type: DRUG

Other Intervention Names

Ferinject, Injectafer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

Hospital Aleman

OTHER

Sponsor Role: lead

Responsible Party

Jorge Eduardo Toblli

Full Professor of Medicine at University of Buenos Aires, Argentina, and Director of the Laboratory of Experimental Medicine, Hospital Alemán, Buenos Aires.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge E Toblli, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Aleman

Locations

Hospital Alemán

Buenos Aires, , Argentina

Countries

Argentina

References

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.

Reference Type: DERIVED

PMID: 25928811 (View on PubMed)

Other Identifiers

FCM-ND-CKD 2012

Identifier Type: -

Identifier Source: org_study_id