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

Phase 4

Completed

• Conditions: Anaemia; Iron Deficiency
• Interventions: Drug: intravenous ferric carboxymaltose

• Registration Number: NCT02232906
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted: 2014-08-31
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-03
• Last Update Submitted: 2014-09-03
• Study First Posted: 2014-09-05
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous ferric carboxymaltose	intravenous ferric carboxymaltose	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of adverse reactions	6 months
Proteinuria at baseline and then bi-monthly until end of study as marker of renal function	6 months
Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function	6 months
Number of transfusions	6 months
Number of hospitalizations	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

Trial Locations

Locations (1)

Hospital Alemán; 🇦🇷 Buenos Aires, Argentina