NCT02232906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

2.5 years

First QC Date

August 31, 2014

Last Update Submit

September 3, 2014

Conditions

Iron DeficiencyAnaemia

Keywords

Chronic kidney diseaseCKDnon-dialysis-dependentND-CKDErythropoiesis-stimulating agentFerric carboxymaltoseIron

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (6)

  • Anaemia and iron status

    6 months

  • Number of hospitalizations

    6 months

  • Number of transfusions

    6 months

  • Number of adverse reactions

    6 months

  • Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function

    6 months

  • +1 more secondary outcomes

Study Arms (1)

intravenous ferric carboxymaltose

EXPERIMENTAL
Drug: intravenous ferric carboxymaltose

Interventions

intravenous ferric carboxymaltoseDRUG

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%)

Also known as: Ferinject, Injectafer
intravenous ferric carboxymaltose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Alemán

Buenos Aires, 1118, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 25928811DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemiaRenal Insufficiency, Chronic

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jorge E Toblli, Prof., MD

    Hospital Aleman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Medicine at University of Buenos Aires, Argentina, and Director of the Laboratory of Experimental Medicine, Hospital Alemán, Buenos Aires.

Study Record Dates

First Submitted

August 31, 2014

First Posted

September 5, 2014

Study Start

March 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

AR(1)