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Trial record 4 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT02232906
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Jorge Eduardo Toblli, Hospital Aleman

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 adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anaemia Drug: intravenous ferric carboxymaltose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: intravenous ferric carboxymaltose 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%)
Other Name: Ferinject, Injectafer




Primary Outcome Measures :
  1. ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Anaemia and iron status [ Time Frame: 6 months ]
    Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study

  2. Number of hospitalizations [ Time Frame: 6 months ]
  3. Number of transfusions [ Time Frame: 6 months ]
  4. Number of adverse reactions [ Time Frame: 6 months ]
  5. Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function [ Time Frame: 6 months ]
  6. Proteinuria at baseline and then bi-monthly until end of study as marker of renal function [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232906


Locations
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Argentina
Hospital Alemán
Buenos Aires, Argentina, 1118
Sponsors and Collaborators
Hospital Aleman
Vifor Pharma
Investigators
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Principal Investigator: Jorge E Toblli, Prof., MD Hospital Aleman

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jorge Eduardo Toblli, Full Professor of Medicine at University of Buenos Aires, Argentina, and Director of the Laboratory of Experimental Medicine, Hospital Alemán, Buenos Aires., Hospital Aleman
ClinicalTrials.gov Identifier: NCT02232906     History of Changes
Other Study ID Numbers: FCM-ND-CKD 2012
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014
Keywords provided by Jorge Eduardo Toblli, Hospital Aleman:
Chronic kidney disease
CKD
non-dialysis-dependent
ND-CKD
Erythropoiesis-stimulating agent
Ferric carboxymaltose
Iron
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Ferric Compounds
Hematinics