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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02232906
Other study ID # FCM-ND-CKD 2012
Secondary ID
Status Completed
Phase Phase 4
First received August 31, 2014
Last updated September 3, 2014
Start date March 2011
Est. completion date September 2013

Study information

Verified date September 2014
Source Hospital Aleman
Contact n/a
Is FDA regulated No
Health authority Argentina: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
intravenous ferric carboxymaltose
Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation >20%)

Locations

Country Name City State
Argentina Hospital Alemán Buenos Aires

Sponsors (2)

Lead Sponsor Collaborator
Hospital Aleman Vifor Pharma

Country where clinical trial is conducted

Argentina, 

Outcome

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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