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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02232906
• Date of registration: 31/08/2014
• Prospective Registration: No
• Primary sponsor: Hospital Aleman
• Public title: Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)
• Scientific title: 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
• Date of first enrolment: March 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02232906
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Jorge E Toblli, Prof., MD
• Affiliation: Hospital Aleman

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anaemia

Iron Deficiency

Intervention(s)

Drug: intravenous ferric carboxymaltose

Primary Outcome(s)

ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment [Time Frame: 6 months]

Secondary Outcome(s)

Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function [Time Frame: 6 months]

Number of adverse reactions [Time Frame: 6 months]

Proteinuria at baseline and then bi-monthly until end of study as marker of renal function [Time Frame: 6 months]

Number of transfusions [Time Frame: 6 months]

Anaemia and iron status [Time Frame: 6 months]

Number of hospitalizations [Time Frame: 6 months]

Secondary ID(s)

FCM-ND-CKD 2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vifor Pharma