A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer

NCT ID: NCT02905539

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-06-30

Brief Summary

The purpose of this study is to determine to what extend a treatment with the iron compounds Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study the potential clinical impact of hypophosphatemia.

Detailed Description

Recent studies suggested that intravenous iron preparations for anemia treatment may have adverse effects on phosphorus regulation, as they may induce an increase in the phosphaturic hormone Fibroblast Growth Factor-23 (FGF-23) and a subsequent fall in plasma phosphorus levels.

So far it is unknown if these effects are class- or substance-specific.

This study will address the question whether among female participants with iron deficiency anemia the application of ferric-(III)-derisomaltose and ferric carboxymaltose will cause episodes of hypophosphatemia to same extend. The investigators will additionally compare the effects of the two iron preparations on other parameters of calcium-phosphate metabolism, and decipher potential consequences of hypophosphatemia by analysing cardiac function, immunological parameters and quality of life.

In order to investigate these outcomes, 60 women with iron deficient anemia will be randomised to receive either ferric-(III)-derisomaltose or ferric carboxymaltose.

The monocentric study will be conducted at Saarland University Medical Center. For each participating woman, the study comprises five visits to the study center during a period of five weeks.

Conditions

Anemia, Iron-Deficiency

Keywords

Iron; anemia; phosphorus; FGF-23

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Iron Isomaltoside 1000

Subjects receive Iron Isomaltoside 1000 solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg.

Group Type: EXPERIMENTAL

Iron Isomaltoside 1000

Intervention Type: DRUG

Ferric Carboxymaltose

Subjects receive Ferric Carboxymaltose solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg.

Group Type: ACTIVE_COMPARATOR

Ferric Carboxymaltose

Intervention Type: DRUG

Interventions

Iron Isomaltoside 1000

Intervention Type: DRUG

Ferric Carboxymaltose

Intervention Type: DRUG

Other Intervention Names

Monofer; Ferinject

Eligibility Criteria

Inclusion Criteria

• written informed consent,
• female,
• gynecological blood losses,
• age ≥ 18 years,
• iron deficiency anemia,
• Hemoglobin < 12,0 g/dl,
• Serum-Ferritin ≤ 100 ng/ml or Serum-Ferritin ≤ 300 ng/ml and Transferrin-saturation ≤ 30 %,
• Intolerance to or inefficacy of an oral iron supplement
• estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²

Exclusion Criteria

• known hypersensitivity to MonoFer® or FERINJECT®,
• severe, known hypersensitivity to other intravenous iron preparations,
• Plasma Phosphate < 2.5 mg/dl at screening,
• Hemochromatosis,
• Untreated hyperparathyroidism,
• Renal replacement therapy/kidney transplantation,
• Active malignant disease, disease-free survival for less than 5 years,
• Intravenous iron administration within the last 30 days,
• Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
• Surgery under anesthetic within the last 10 days,
• Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
• Acute febrile infections within the last 7 days,
• Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
• self-reported severe asthma or eczema,
• presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
• pregnancy,
• women of childbearing potential without an effective method of contraception,
• lactating women,
• Present alcohol or drug dependency,
• Patients with a history of a psychological illness or seizures,
• Non-compliance or administration of any investigational drug within 30 days preceding the study start.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universität des Saarlandes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar Heine, MD

Role: PRINCIPAL_INVESTIGATOR

Universität des Saarlandes

Danilo Fliser, MD

Role: STUDY_DIRECTOR

Universität des Saarlandes

Locations

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Countries

Germany

References

Emrich IE, Lizzi F, Siegel JD, Seiler-Mussler S, Ukena C, Kaddu-Mulindwa D, D'Amelio R, Wagenpfeil S, Brandenburg VM, Bohm M, Fliser D, Heine GH. Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study. BMC Med. 2020 Jul 13;18(1):178. doi: 10.1186/s12916-020-01643-5.

Reference Type: DERIVED

PMID: 32654663 (View on PubMed)

Other Identifiers

2015-004808-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1176-4563

Identifier Type: REGISTRY

Identifier Source: secondary_id

DRKS00010766

Identifier Type: REGISTRY

Identifier Source: secondary_id

P-0101

Identifier Type: -

Identifier Source: org_study_id