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OpenTrials
Completed

NCT Number: NCT02232906

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

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.

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Key information

Conditions

Iron Deficiency Anaemia Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Alemán

Buenos Aires, 1118, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous ferric carboxymaltose

Drug

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 names: Ferinject, Injectafer

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Aleman

Other

Collaborators

  • Vifor Pharma

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2014
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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