Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 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 Due to Inflammatory Bowel Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03466983
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

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

Condition or disease Intervention/treatment Phase
IBD Drug: Iron Isomaltoside Drug: Ferric Carboxymaltose Phase 4

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 .


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blinded
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Iron Isomaltoside
Iron Isomaltoside (Monofer) administered IV
Drug: Iron Isomaltoside
administered IV
Other Name: Monofer

Active Comparator: Ferric Carboxymaltose
Ferric Carboxymaltose (Injectafer) administered IV
Drug: Ferric Carboxymaltose
administered IV
Other Name: Ferinject




Primary Outcome Measures :
  1. Incidence of hypophosphatemia [ Time Frame: any time from baseline to day 35 ]
    s-phosphate < 2 mg/dL


Secondary Outcome Measures :
  1. Incidence of hypophosphatemia [ Time Frame: any time from baseline to week 10 ]
    s-phosphate < 2 mg/dL

  2. Incidence of s-phosphate < 1.0 mg/dL [ Time Frame: any time from baseline to day 35 ]
    s-phosphate < 1.0 mg/dL

  3. Time with hypophosphatemia [ Time Frame: number of days any time from baseline to week 10 ]
    time with s-phosphate < 2.0 mg/dL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466983


Contacts
Layout table for location contacts
Contact: Lars L Thomsen, MD +4559485959 info@pharmacosmos.com

Locations
Layout table for location information
Denmark
Regionshospitalet Silkeborg Recruiting
Silkeborg, Denmark, 8600
Contact: Ole K Bonderup, MD         
Sponsors and Collaborators
Pharmacosmos A/S

Layout table for additonal information
Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03466983     History of Changes
Other Study ID Numbers: P-Monofer-IBD-03
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Inflammatory Bowel Diseases
Anemia, Iron-Deficiency
Hypophosphatemia
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Phosphorus Metabolism Disorders
Iron
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics