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

Primary Purpose

Iron Deficiency, Anaemia

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
intravenous ferric carboxymaltose
Sponsored by
Hospital Aleman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency focused on measuring Chronic kidney disease, CKD, non-dialysis-dependent, ND-CKD, Erythropoiesis-stimulating agent, Ferric carboxymaltose, Iron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Alemán

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravenous ferric carboxymaltose

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anaemia and iron status
Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study
Number of hospitalizations
Number of transfusions
Number of adverse reactions
Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
Proteinuria at baseline and then bi-monthly until end of study as marker of renal function

Full Information

First Posted
August 31, 2014
Last Updated
September 3, 2014
Sponsor
Hospital Aleman
Collaborators
Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02232906
Brief Title
Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Aleman
Collaborators
Vifor Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anaemia
Keywords
Chronic kidney disease, CKD, non-dialysis-dependent, ND-CKD, Erythropoiesis-stimulating agent, Ferric carboxymaltose, Iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravenous ferric carboxymaltose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
intravenous ferric carboxymaltose
Other Intervention Name(s)
Ferinject, Injectafer
Intervention Description
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%)
Primary Outcome Measure Information:
Title
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Anaemia and iron status
Description
Hemoglobin, mean corpuscular volume, serum ferritin and transferrin saturation were assessed at baseline and monthly until end of study
Time Frame
6 months
Title
Number of hospitalizations
Time Frame
6 months
Title
Number of transfusions
Time Frame
6 months
Title
Number of adverse reactions
Time Frame
6 months
Title
Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
Time Frame
6 months
Title
Proteinuria at baseline and then bi-monthly until end of study as marker of renal function
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge E Toblli, Prof., MD
Organizational Affiliation
Hospital Aleman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Alemán
City
Buenos Aires
ZIP/Postal Code
1118
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
25928811
Citation
Toblli JE, Di Gennaro F. Switching patients with non-dialysis chronic kidney disease from oral iron to intravenous ferric carboxymaltose: effects on erythropoiesis-stimulating agent requirements, costs, hemoglobin and iron status. PLoS One. 2015 Apr 30;10(4):e0125528. doi: 10.1371/journal.pone.0125528. eCollection 2015.
Results Reference
derived

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

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