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

NCT02905539 | Completed Phase 4

• 4 other identifiers: P-01012015-004808-36U1111-1176-4563DRKS00010766
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron-Deficiency

Keywords

Iron; anemia; phosphorus; FGF-23

Outcome Measures

Primary Outcomes (1)

• Incidence of hypophosphatemia

  The incidence of hypophosphatemia is defined as a drop of serum phosphate below 2.0 mg/dl.

  From baseline to day 35

Secondary Outcomes (22)

• Changes of plasma phosphate concentrations.

  From baseline to day 35

• Changes of fractional Phosphate urinary excretion.

  From baseline to day 35

• Changes of Plasma Vitamin D (active, inactive).

  From baseline to day 35

• Changes of fibroblast growth factor 23 (intact and c-terminal).

  From baseline to day 35

• Changes of parathyroid Hormone.

  From baseline to day 35

Study Arms (2)

Iron Isomaltoside 1000

EXPERIMENTAL

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.

Drug: Iron Isomaltoside 1000

Ferric Carboxymaltose

ACTIVE COMPARATOR

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.

Drug: Ferric Carboxymaltose

Interventions

Iron Isomaltoside 1000 DRUG

Also known as: Monofer

Iron Isomaltoside 1000

Ferric Carboxymaltose DRUG

Also known as: Ferinject

Ferric Carboxymaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Related Publications (1)

• 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.

  PMID: 32654663 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

iron isomaltoside 1000; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gunnar Heine, MD

  Universität des Saarlandes

  PRINCIPAL INVESTIGATOR

• Danilo Fliser, MD

  Universität des Saarlandes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 19, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 30, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)