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

Iron Deficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232906
• Other study ID #: FCM-ND-CKD 2012
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2014
• Last updated: September 3, 2014
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Hospital Aleman
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaemia
• Anemia, Iron-Deficiency
• Iron Deficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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%)

Locations

Country	Name	City	State
Argentina	Hospital Alemán	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Aleman	Vifor Pharma

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment		6 months	No
Secondary	Anaemia and iron status	Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study	6 months	No
Secondary	Number of hospitalizations		6 months	No
Secondary	Number of transfusions		6 months	No
Secondary	Number of adverse reactions		6 months	Yes
Secondary	Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function		6 months	Yes
Secondary	Proteinuria at baseline and then bi-monthly until end of study as marker of renal function		6 months	Yes