Phase 3
Completed N=122
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
Iron Deficiency Anaemia · Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT03237065 ↗
Enrolled (actual)
122
Serious AEs
0.8%
Results posted
Feb 2020
Primary outcomePrimary: Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) — 5; 42 Participants — p=<0.0001
◆ Published Evidence
Highly cited
278citations · ~46 / year
Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials.
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).
Linked Publications
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Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) |
5; 42 | <0.0001 sig |
| SECONDARY Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) |
11; 28 | 0.0511 |
| SECONDARY Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL) |
0; 25 | <0.0001 sig |
| SECONDARY Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 |
0.19; -0.18; -0.44; -0.89; -0.46; -1.14 | <0.0001 sig |
| SECONDARY Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 |
6.89; -4.34; -11.99; -25.83; -12.32; -33.36 | <0.0001 sig |
| SECONDARY Change From Baseline in Fractional Phosphate Urinary Excretion |
0.54; 1.77; 1.33; 4.90; 2.29; 6.05 | — |
| SECONDARY Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35 |
-4.18; 93.38; 16.97; 33.60; 8.09; 259.16 | <0.0001 sig |
| SECONDARY Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35 |
-677.38; -843.21; -692.44; -924.44; -753.40; -853.50 | 0.1243 |
| SECONDARY Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35 |
-0.39; -0.25; -0.39; 0.61; -0.92; 0.83 | 0.6869 |
| SECONDARY Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 |
5.89; -16.97; -16.78; -23.92; -12.93; -35.59 | <0.0001 sig |
| SECONDARY Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35 |
0.02; 0.07; 0.31; 0.26; 0.22; 0.38 | 0.5134 |
| SECONDARY Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35 |
-0.07; -7.02; -1.72; 0.73; -0.17; -3.26 | 0.2166 |
| SECONDARY Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35 |
-0.002; 0.047; 0.020; -0.003; 0.016; -0.016 | 0.3048 |
| SECONDARY Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions |
0; 2 | — |
| SECONDARY Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35 |
0.21; 0.46; 0.99; 1.41; 1.08; 0.84 | 0.0882 |
| SECONDARY Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35 |
72.47; 76.96; 252.39; 279.15; 219.36; 313.44 | 0.6568 |
| SECONDARY Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35 |
121.77; 83.78; 15.05; 12.92; 12.27; 73.44 | 0.0503 |
Eligibility Criteria
Inclusion criteria include:
- Subjects having IDA caused by different aetiologies
- Haemoglobin (Hb) ≤ 11 g/dL
- Body weight > 50 kg
- Serum ferritin (S-ferritin) 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.
Data sourced from ClinicalTrials.gov (NCT03237065) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.