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Iron Isomaltoside and Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940886
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE November 21, 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • The primary safety outcome measure is the incidence of protocol defined hypersensitivity reactions (number of participants with such events ) [ Time Frame: 8 weeks ]
  • The primary efficacy outcome is the ability to increase Hb (g/dL). [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02940886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • Protocol defined cardiovascular adverse events (number of participants with such events), [ Time Frame: 8 weeks ]
  • Changes in S- Ferritin (ng/mL) [ Time Frame: 8 weeks ]
  • Changes in Transferrin saturation (%) [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron Isomaltoside and Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
Official Title  ICMJE A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (Ferwon IDA)
Brief Summary Evaluation of safety and efficacy of iron isomaltoside compared to iron sucrose in subjects suffering from IDA
Detailed Description

IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.

This study is designed to evaluate the safety and efficacy of iron isomaltoside compared to iron sucrose in subjects suffering from IDA. In a subfraction of 35 subjects treated with iron isomaltoside ECG and iron will be measured frequently

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • Drug: Iron isomaltoside
  • Drug: Iron sucrose
Study Arms  ICMJE
  • Experimental: Iron isomaltoside (Monofer)
    Administered iv
    Intervention: Drug: Iron isomaltoside
  • Active Comparator: Iron sucrose (Venofer)
    Administered iv
    Intervention: Drug: Iron sucrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
1512
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
1500
Actual Study Completion Date  ICMJE March 28, 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria includes:

  1. Men or women ≥ 18 years
  2. Subjects having IDA caused by different etiologies
  3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
  4. Hb ≤ 11 g/dL
  5. TSAT < 20 %
  6. S-ferritin < 100 ng/mL
  7. Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

  1. Anemia predominantly caused by factors other than IDA
  2. Hemochromatosis or other iron storage disorders
  3. Previous serious hypersensitivity reactions to any IV iron compound
  4. Erythropoiesis stimulating agent (ESA) treatment
  5. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
  6. Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
  7. Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal
  8. Required dialysis for treatment of CKD
  9. Alcohol or drug abuse within the past 6 months
  10. Pregnant or nursing women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02940886
Other Study ID Numbers  ICMJE P-Monofer-IDA-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pharmacosmos A/S
Study Sponsor  ICMJE Pharmacosmos A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pharmacosmos A/S
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP