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
Verified date | September 2014 |
Source | Hospital Aleman |
Contact | n/a |
Is FDA regulated | No |
Health authority | Argentina: Ministry of Health |
Study type | Interventional |
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Alemán | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital Aleman | Vifor Pharma |
Argentina,
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 |
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