Status:
COMPLETED
Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)
Lead Sponsor:
Hospital Aleman
Collaborating Sponsors:
Vifor Pharma
Conditions:
Iron Deficiency
Anaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 adul...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02232906
Start Date
March 1 2011
End Date
September 1 2013
Last Update
September 5 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Alemán
Buenos Aires, Argentina, 1118