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Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia

NCT02243735 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2018-08-28

No results posted yet for this study

Summary

The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the anemia and the assess the effect of preoperative iron on morbidity, postoperative recovery and quality of life.

Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with intravenous iron will lead to a higher percentage of patients with normalization of Hb-level (\> 12 g/dl (7.5 mmol/l) for women and \> 13 g/dl (8 mmol/l) for men), which potentially reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be more cost effective compared to current practice with oral substitution of iron.

Conditions

  • Anemia
  • Colorectal Carcinoma
  • Surgery

Interventions

DRUG

Ferrous fumarate

Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery

DRUG

ferric(III)carboxymaltose

Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • W. A Bemelman, Proffessor · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243735 on ClinicalTrials.gov