Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
- Conditions
- Iron Deficiency AnaemiaIron Deficiency Anemia
- Interventions
- Registration Number
- NCT03238911
- Lead Sponsor
- Pharmacosmos A/S
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron isomaltoside/ferric derisomaltose Iron isomaltoside/ferric derisomaltose Administered IV Ferric carboxymaltose Ferric carboxymaltose Administered IV
- Primary Outcome Measures
Name Time Method Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) 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.
- Secondary Outcome Measures
Name Time Method Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) 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) 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 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 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 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 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 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 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 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 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 35Change 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 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 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 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 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 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 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.
Trial Locations
- Locations (3)
Pharmacosmos Investigational Site
🇺🇸Leesburg, Virginia, United States
Pharmacosmos Investigational Site 2
🇺🇸Miami, Florida, United States
Pharmacosmos Investigational Site 1
🇺🇸Miami, Florida, United States