Status:
COMPLETED
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
Lead Sponsor:
Pharmacosmos A/S
Conditions:
Iron Deficiency Anaemia
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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).
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2018
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03237065
Start Date
October 30 2017
End Date
May 29 2018
Last Update
February 25 2020
Active Locations (15)
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1
Pharmacosmos Investigational Site
Muscle Shoals, Alabama, United States, 35661
2
Pharmacosmos Investigational Site
Doral, Florida, United States, 33122
3
Pharmacosmos Investigational Site
Miami, Florida, United States, 33144
4
Pharmacosmos Investigational Site
Miami, Florida, United States, 33165