Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
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ClinicalTrials.gov Identifier: NCT03237065 |
Recruitment Status :
Completed
First Posted : August 2, 2017
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Iron Deficiency Anaemia Iron Deficiency Anemia | Drug: Iron isomaltoside/ferric derisomaltose Drug: Ferric carboxymaltose | Phase 3 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 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-05) |
Actual Study Start Date : | October 30, 2017 |
Actual Primary Completion Date : | May 29, 2018 |
Actual Study Completion Date : | May 29, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Iron isomaltoside/ferric derisomaltose
Administered IV
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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. 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 Name: Injectafer®, Ferinject® |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 %.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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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 |
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.

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): NCT03237065
United States, Alabama | |
Pharmacosmos Investigational Site | |
Muscle Shoals, Alabama, United States, 35661 | |
United States, Florida | |
Pharmacosmos Investigational Site | |
Doral, Florida, United States, 33122 | |
Pharmacosmos Investigational Site | |
Miami Lakes, Florida, United States, 33014 | |
Pharmacosmos Investigational Site | |
Miami, Florida, United States, 33144 | |
Pharmacosmos Investigational Site | |
Miami, Florida, United States, 33165 | |
Pharmacosmos Investigational Site | |
Orlando, Florida, United States, 32819 | |
United States, Idaho | |
Pharmacosmos Investigational Site | |
Idaho Falls, Idaho, United States, 83404 | |
United States, Illinois | |
Pharmacosmos Investigational Site | |
Oak Brook, Illinois, United States, 60523 | |
United States, Michigan | |
Pharmacosmos investigational Site | |
Flint, Michigan, United States, 48504 | |
United States, Missouri | |
Pharmacosmos Investigational Site | |
Saint Louis, Missouri, United States, 63119 | |
United States, Nevada | |
Pharmacosmos Investigational Site | |
Las Vegas, Nevada, United States, 89146 | |
United States, New Mexico | |
Pharmacosmos Investigational Site | |
Albuquerque, New Mexico, United States, 87102 | |
United States, North Carolina | |
Pharmacosmos Investigational Site | |
Morehead City, North Carolina, United States, 28557 | |
Pharmacosmos Investigational Site | |
Raleigh, North Carolina, United States, 27607 | |
Pharmacosmos Investigational Site | |
Winston-Salem, North Carolina, United States, 27103 |
Study Director: | Pharmacosmos A/S Clinical and Non-clinical Research | Pharmacosmos A/S |
Documents provided by Pharmacosmos A/S:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pharmacosmos A/S |
ClinicalTrials.gov Identifier: | NCT03237065 |
Other Study ID Numbers: |
P-Monofer-IDA-05 |
First Posted: | August 2, 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Iron Deficiency Anaemia Iron Deficiency Anemia IDA Iron deficiency Intravenous iron replacement therapy Iron isomaltoside Ferric derisomaltose |
Hypophosphatemia Ferric carboxymaltose Monofer Monoferric Monover Monofar Monoferro |
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 |