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

Sponsors

Lead Sponsor: Hospital Aleman

Collaborator: Vifor Pharma

Source Hospital Aleman
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.

Overall Status Completed
Start Date March 2011
Completion Date September 2013
Primary Completion Date September 2013
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment 6 months
Secondary Outcome
Measure Time Frame
Anaemia and iron status 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
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: intravenous ferric carboxymaltose

Description: 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%)

Arm Group Label: intravenous ferric carboxymaltose

Other Name: 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jorge E Toblli, Prof., MD Principal Investigator Hospital Aleman
Location
Facility: Hospital Alemán
Location Countries

Argentina

Verification Date

September 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital Aleman

Investigator Full Name: Jorge Eduardo Toblli

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

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: intravenous ferric carboxymaltose

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov