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

September 3, 2014 updated by: Jorge Eduardo Toblli, Hospital Aleman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1118
        • Hospital Aleman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Ferinject, Injectafer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Number of hospitalizations
Time Frame: 6 months
6 months
Number of transfusions
Time Frame: 6 months
6 months
Number of adverse reactions
Time Frame: 6 months
6 months
Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
Time Frame: 6 months
6 months
Proteinuria at baseline and then bi-monthly until end of study as marker of renal function
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Aleman

Collaborators

Vifor Pharma

Investigators

  • Principal Investigator: Jorge E Toblli, Prof., MD, Hospital Aleman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 31, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 3, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCM-ND-CKD 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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