CompletedPhase 4

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

Argentina30 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment

Timeframe: 6 months

Trial details

NCT IDNCT02232906

SponsorHospital Aleman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

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