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A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03466983
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE March 15, 2018
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE May 23, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Incidence of hypophosphatemia [ Time Frame: any time from baseline to day 35 ]
s-phosphate < 2 mg/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Incidence of hypophosphatemia [ Time Frame: any time from baseline to week 10 ]
    s-phosphate < 2 mg/dL
  • Incidence of s-phosphate < 1.0 mg/dL [ Time Frame: any time from baseline to day 35 ]
    s-phosphate < 1.0 mg/dL
  • Time with hypophosphatemia [ Time Frame: number of days any time from baseline to week 10 ]
    time with s-phosphate < 2.0 mg/dL
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 A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
Official Title  ICMJE A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
Brief Summary Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia
Detailed Description

Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.

This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blinded
Primary Purpose: Treatment
Condition  ICMJE IBD
Intervention  ICMJE
  • Drug: Iron Isomaltoside
    administered IV
    Other Name: Monofer
  • Drug: Ferric Carboxymaltose
    administered IV
    Other Name: Ferinject
Study Arms  ICMJE
  • Experimental: Iron Isomaltoside
    Iron Isomaltoside (Monofer) administered IV
    Intervention: Drug: Iron Isomaltoside
  • Active Comparator: Ferric Carboxymaltose
    Ferric Carboxymaltose (Injectafer) administered IV
    Intervention: Drug: Ferric Carboxymaltose
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria include:

  • Men or women ≥ 18 years
  • Subjects diagnosed with IBD
  • Hb < 13 g/dL
  • Body weight ≥ 50 kg
  • S-ferritin <100 ng/mL
  • eGFR ≥ 65 mL/min/1.73 m2
  • S-phosphate > 2.5 mg/dL
  • Oral iron preparations are ineffective or cannot be used or where there is a clinical need to de-liver iron rapidly
  • Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

  • Anaemia predominantly caused by factors other than IDA according to Investigator's judgment
  • Hb ≥ 10 g/dL and body weight < 70 kg
  • Hemochromatosis or other iron storage disorders
  • Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
  • Previous serious hypersensitivity reactions to any IV iron compounds
  • Treatment with IV iron within the last 30 days prior to screening
  • Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, and/or chemotherapy within the last 30 days prior to screening
  • Received an investigational drug within the last 30 days prior to screening
  • Planned surgical procedure within the trial period
  • hepatic enzymes > 3 times upper limit of normal
  • Surgery under general anaesthesia within the last 30 days prior to screening
  • Any non-viral infection within the last 30 days prior to screening
  • Alcohol or drug abuse within the past 6 months
  • Untreated hyperparathyroidism
  • Kidney transplantation
  • Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance
  • Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
  • 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: Pharmacosmos A/S Clinical and Non-clinical Research +4559485959 info@pharmacosmos.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03466983
Other Study ID Numbers  ICMJE P-Monofer-IBD-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
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 October 2019

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