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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03238911
Other study ID # P-Monofer-IDA-04
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 24, 2017
Est. completion date June 19, 2018

Study information

Verified date February 2020
Source Pharmacosmos A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 123
Est. completion date June 19, 2018
Est. primary completion date June 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria include:

- Subjects diagnosed with 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.

Study Design


Intervention

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).
Ferric carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. Ferric carboxymaltose was administered as 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).

Locations

Country Name City State
United States Pharmacosmos Investigational Site Clearwater Florida
United States Pharmacosmos Investigational Site Houston Texas
United States Pharmacosmos Investigational Site Indianapolis Indiana
United States Pharmacosmos Investigational Site Lancaster Pennsylvania
United States Pharmacosmos Investigational Site Leesburg Virginia
United States Pharmacosmos Investigational Site Los Angeles California
United States Pharmacosmos Investigational Site Metairie Louisiana
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site Miami Florida
United States Pharmacosmos Investigational Site 1 Miami Florida
United States Pharmacosmos Investigational Site 2 Miami Florida
United States Pharmacosmos Investigational Site Orem Utah
United States Pharmacosmos Investigational Site Sacramento California
United States Pharmacosmos Investigational Site Santa Ana California
United States Pharmacosmos Investigational Site Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Pharmacosmos A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials.

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL) Safety
The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35.
Baseline to day 35
Secondary Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL) 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.
Baseline to day 35
Secondary Proportion of Subjects With Hypophosphatemia on Day 35 ( S-phosphate Level <2.0 mg/dL) Safety
Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35.
Baseline to day 35
Secondary Absolute [?] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 Safety
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
Secondary Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35 Safety
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
Secondary Change From Baseline in Fractional Phosphate Urinary Excretion 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 %.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 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.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to 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.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to 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.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to 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.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to 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
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in Intact Parathyroid Hormone (PTH) From Baseline to 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.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35 Safety
Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions Safety
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.
Baseline to day 35
Secondary Change in Hemoglobin (Hb) Per Gram Iron From Baseline to 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.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35 Efficacy
Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.
Baseline, days 1, 7, 8, 14, 21, and 35
Secondary Change in Transferrin Saturation (TSAT) From Baseline to 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.
Baseline, days 1, 7, 8, 14, 21, and 35
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