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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Aleman
• Collaborator: Vifor Pharma
• Treatments: Ferric Compounds

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