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Trial record 12 of 36 for:    pharmacosmos

A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (IDA-04)

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ClinicalTrials.gov Identifier: NCT03238911
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE July 6, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE October 24, 2017
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Incidence of hypophosphatemia (defined as s-phosphate < 2 mg/dL) [ Time Frame: At any time point within 35 days after beginning of treatment with trial drugs ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03238911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • Incidence of s-phosphate < 1.0 mg/dL [ Time Frame: 35 days ]
  • Time with hypophosphatemia [ Time Frame: 35 days ]
    time with s-phosphate < 2.0 mg/dL
  • Proportion of subjects with hypophosphatemia [ Time Frame: day 35 ]
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 (IDA-04)
Official Title  ICMJE A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (IDA-04)
Brief Summary Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia 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.

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 IDA - Iron Deficiency Anemia
Intervention  ICMJE
  • Drug: Iron isomaltoside (Monofer)
    administered IV
  • Drug: Ferric carboxymaltose
    administered IV
    Other Name: Injectafer
Study Arms  ICMJE
  • Experimental: Iron Isomaltoside
    Iron Isomaltoside (Monofer) administered IV
    Intervention: Drug: Iron isomaltoside (Monofer)
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
123
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2017)
120
Actual Study Completion Date  ICMJE June 19, 2018
Actual Primary Completion Date June 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria include:

  • subjects having IDA caused by different aetiologies
  • Hb ≤ 11 g/dL
  • Body weight > 50 kg
  • S-ferritin < 100 ng/mL
  • eGFR ≥ 65 mL/min/1.73 m2
  • S-phosphate > 2.5 mg/dL
  • intolerance or unresponsiveness to oral iron
  • Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

  • Acute bleeding > 500 mL within 72 hours
  • Anaemia predominantly caused by factors other than IDA
  • Hemochromatosis or other iron storage disorders
  • 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
  • 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 anaesthetic 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
  • Vitamin D deficiency
  • Untreated hyperparathyroidism
  • Kidney transplantation
  • Active malignant disease, disease-free for less than 5 years
  • History of a psychological illness or seizures
  • Pregnant or nursing women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
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 NCT03238911
Other Study ID Numbers  ICMJE P-Monofer-IDA-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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 May 2019

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