- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03237065
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
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-05)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Muscle Shoals, Alabama, United States, 35661
- Pharmacosmos Investigational Site
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Florida
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Doral, Florida, United States, 33122
- Pharmacosmos Investigational Site
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Miami, Florida, United States, 33165
- Pharmacosmos Investigational Site
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Miami, Florida, United States, 33144
- Pharmacosmos Investigational Site
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Miami Lakes, Florida, United States, 33014
- Pharmacosmos Investigational Site
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Orlando, Florida, United States, 32819
- Pharmacosmos Investigational Site
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Pharmacosmos Investigational Site
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Illinois
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Oak Brook, Illinois, United States, 60523
- Pharmacosmos Investigational Site
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Michigan
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Flint, Michigan, United States, 48504
- Pharmacosmos Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63119
- Pharmacosmos Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89146
- Pharmacosmos Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Pharmacosmos Investigational Site
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North Carolina
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Morehead City, North Carolina, United States, 28557
- Pharmacosmos Investigational Site
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Raleigh, North Carolina, United States, 27607
- Pharmacosmos Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Pharmacosmos Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria include:
- Subjects having 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Iron isomaltoside/ferric derisomaltose
Administered IV
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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 Names:
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ACTIVE_COMPARATOR: Ferric carboxymaltose
Administered IV
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Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial.
The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
Time Frame: Baseline to day 35
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Safety The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35. |
Baseline to day 35
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)
Time Frame: Baseline to day 35
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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. |
Baseline to day 35
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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
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Safety Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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Change From Baseline in Fractional Phosphate Urinary Excretion
Time Frame: Baseline, days 1, 7, 8, 14, 21, and 35
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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 %. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Safety Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Time Frame: Baseline to day 35
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Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. |
Baseline to day 35
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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
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Efficacy Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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Efficacy Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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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
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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. |
Baseline, days 1, 7, 8, 14, 21, and 35
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Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)
Time Frame: Baseline to day 35
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Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35. |
Baseline to day 35
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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
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Safety Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35. |
Baseline, days 1, 7, 8, 14, 21, and 35
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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
- Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, Thomsen LL, Carpenter TO, Weber T, Brandenburg V, Zoller H. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. doi: 10.1001/jama.2019.22450.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-Monofer-IDA-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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