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Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

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ClinicalTrials.gov Identifier: NCT03238911
Recruitment Status : Completed
First Posted : August 3, 2017
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anaemia Iron Deficiency Anemia Drug: Iron isomaltoside/ferric derisomaltose Drug: Ferric carboxymaltose Phase 3

Detailed Description:

This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.

The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric Derisomaltose and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (Phosphare-IDA-04)
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Iron isomaltoside/ferric derisomaltose
Administered IV
Drug: Iron isomaltoside/ferric derisomaltose

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.

The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).

Other Name: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®

Active Comparator: Ferric carboxymaltose
Administered IV
Drug: Ferric carboxymaltose

Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial.

Ferric carboxymaltose was administered as 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).

Other Name: Injectafer®, Ferinject®




Primary Outcome Measures :
  1. Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) [ Time Frame: Baseline to day 35 ]

    Safety

    The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35.



Secondary Outcome Measures :
  1. Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) [ Time Frame: Baseline to day 35 ]

    Safety

    Time with hypophosphatemia (i.e. time with s-phosphate level < 2.0 mg/dL) from baseline up to day 35.

    The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was <2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.


  2. Proportion of Subjects With Hypophosphatemia on Day 35 ( S-phosphate Level <2.0 mg/dL) [ Time Frame: Baseline to day 35 ]

    Safety

    Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35.


  3. Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.


  4. Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.


  5. Change From Baseline in Fractional Phosphate Urinary Excretion [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.

    Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %.


  6. Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.


  7. Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.


  8. Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.


  9. Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.


  10. Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35


  11. Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.


  12. Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Safety

    Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.


  13. Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions [ Time Frame: Baseline to day 35 ]

    Safety

    For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.


  14. Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Efficacy

    Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.


  15. Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Efficacy

    Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.


  16. Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35 [ Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35 ]

    Efficacy

    Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.

    TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.




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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  • Subjects diagnosed with IDA, caused by different aetiologies
  • Haemoglobin (Hb) ≤ 11 g/dL
  • Body weight > 50 kg
  • Serum ferritin (S-ferritin) < 100 ng/mL
  • Estimated glomerular filtration rate (eGFR) ≥ 65 mL/min/1.73 m2
  • Serum phosphate (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.

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): NCT03238911


Locations
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United States, California
Pharmacosmos Investigational Site
Los Angeles, California, United States, 90036
Pharmacosmos Investigational Site
Sacramento, California, United States, 95831
Pharmacosmos Investigational Site
Santa Ana, California, United States, 92704
United States, Florida
Pharmacosmos Investigational Site
Clearwater, Florida, United States, 33759
Pharmacosmos Investigational Site
Miami, Florida, United States, 33125
Pharmacosmos Investigational Site 1
Miami, Florida, United States, 33126
Pharmacosmos Investigational Site 2
Miami, Florida, United States, 33126
Pharmacosmos Investigational Site
Miami, Florida, United States, 33143
Pharmacosmos Investigational Site
Miami, Florida, United States, 33144
United States, Indiana
Pharmacosmos Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
Pharmacosmos Investigational Site
Wichita, Kansas, United States, 67206
United States, Louisiana
Pharmacosmos Investigational Site
Metairie, Louisiana, United States, 70001
United States, Pennsylvania
Pharmacosmos Investigational Site
Lancaster, Pennsylvania, United States, 17605
United States, Texas
Pharmacosmos Investigational Site
Houston, Texas, United States, 77024
United States, Utah
Pharmacosmos Investigational Site
Orem, Utah, United States, 84058
United States, Virginia
Pharmacosmos Investigational Site
Leesburg, Virginia, United States, 20176
Sponsors and Collaborators
Pharmacosmos A/S
Investigators
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Study Director: Pharmacosmos A/S Clinical and Non-clinical Research Pharmacosmos A/S
  Study Documents (Full-Text)

Documents provided by Pharmacosmos A/S:
Study Protocol  [PDF] November 29, 2017
Statistical Analysis Plan  [PDF] March 12, 2018

Additional Information:
Publications of Results:
Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03238911    
Other Study ID Numbers: P-Monofer-IDA-04
First Posted: August 3, 2017    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharmacosmos A/S:
Iron Deficiency Anaemia
Iron Deficiency Anemia
IDA
Intravenous iron replacement therapy
Iron deficiency
Iron isomaltoside
Ferric derisomaltose
Monofer
Monoferric
Monover
Monofar
Monoferro
Hypophosphatemia
Ferric carboxymaltose
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hypophosphatemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Phosphorus Metabolism Disorders
Iron isomaltoside 1000
Hematinics