Phase 3 N=123 Randomized Treatment

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

Iron Deficiency Anaemia · Iron Deficiency Anemia

Bottom Line

View on ClinicalTrials.gov: NCT03238911 ↗

Enrolled (actual)

123

Serious AEs

0.8%

Results posted

Feb 2020

Primary outcome: Primary: Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) — 5; 45 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Iron isomaltoside/ferric derisomaltose (Drug); Ferric carboxymaltose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pharmacosmos A/S
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)	5; 45	<0.0001 sig
SECONDARY Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)	15; 29	0.8979
SECONDARY Proportion of Subjects With Hypophosphatemia on Day 35 ( S-phosphate Level <2.0 mg/dL)	1; 24	<0.0001 sig
SECONDARY Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	0.25; -0.24; -0.06; -1.15; -0.10; -1.15	<0.0001 sig
SECONDARY Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35	9.31; -5.94; 0.55; -33.68; -0.95; -34.03	<0.0001 sig
SECONDARY Change From Baseline in Fractional Phosphate Urinary Excretion	-1.73; 2.44; 0.56; 8.12; 1.21; 9.08	—
SECONDARY Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35	-2.7; 103.6; 6.8; 70.3; 4.9; 305.9	<0.0001 sig
SECONDARY Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35	-742.3; -390.2; -723.6; -477.5; -648.9; -284.2	<0.0001 sig
SECONDARY Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35	0.04; 0.32; 0.81; -0.94; 0.32; -0.07	0.5620
SECONDARY Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35	5.13; -20.57; -19.92; -38.84; -16.07; -39.63	<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; 0.13; 0.30; 0.72; 0.19; 0.71	0.0552
SECONDARY Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35	-1.3; 0.7; -4.6; 7.8; 1.8; 2.6	0.7447
SECONDARY Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35	0.04; 0.00; 0.02; -0.07; 0.03; -0.03	0.2670
SECONDARY Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions	1; 0	—
SECONDARY Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35	-0.16; 0.28; 0.65; 0.94; 0.50; 0.64	0.4618
SECONDARY Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35	82.0; 94.7; 261.7; 289.5; 248.1; 325.8	0.1922
SECONDARY Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35	118.9; 85.7; 10.2; 12.9; 6.3; 61.2	<0.0001 sig

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).

Eligibility 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) 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03238911). 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.