EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations

NCT03382275 | Completed

• 1 other identifier: EXPLAIN IRON
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

By describing the characteristics of iron deficiency (ID) patients treated with various oral or intravenous iron formulations and their outcomes, this registry will provide the medical community with important information to support treatment decisions for their patients regarding data on effectiveness, safety, tolerability, treatment persistence, quality of life, and therapeutic costs. This will ultimately support improvements to patient care, including the long-term outcomes of patients with ID.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• Hemoglobin

  serum level change compared to baseline

  at 3 months

Secondary Outcomes (3)

• Ferritin

  at 3 months

• Hemoglobin

  2 years

• Ferritin

  2 years

Other Outcomes (8)

• Transferrin saturation

  at 3 months

• Adverse events

  2 years

• Hypophosphatemia

  2 years

Interventions

Iron Supplement DRUG

any oral or intravenous prescription iron supplement

Also known as: Iron bivalent or trivalent oral, Iron trivalent oral, Feraccru (Ferric Maltol)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with iron deficiency in one of the following indications: (i) Inflammatory bower disease, (ii) chronic kidney disease, (iii) cancer- or therapy-induced iron deficiency, (iv) gynaecological conditions (hypermenorrhea, post-partum, fatigue), (v) cardiology (including iron deficiency in patients with congenital heart disease or chronic heart failure), and (vi) diverse other causes of iron deficiency.

You may qualify if:

• Female or male patients, aged at least 18 years
• Clinical diagnosis of iron deficiency according to treating physician
• Decision to treat with an oral or intravenous iron supplementation made by treating physician considering the indications of the respective Summary of Product Characteristics (prescribing information)
• maintenance or newly initiated treatment (including returning quitters)
• written informed consent

You may not qualify if:

• patient not available for long-term documentation
• concomitant or planned participation in a clinical trial (on iron supplementation)
• concomitant over-the-counter iron supplementation

Sponsors & Collaborators

• GWT-TUD GmbH: lead
• Shield Therapeutics: collaborator

Study Sites (2)

Praxis für Gastroenterologie

Berlin, 10318, Germany

Location

Klinik für Innere Medizin I des Universiätsklinikums

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex; ferric maltol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• David Pittrow, MD, PhD

  GWT-TUD GmbH

  STUDY DIRECTOR

• Stefan Schreiber, MD, PhD

  Klinik für Innere Medizin I, Universitätsklinikum Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 22, 2017
• Study Start: January 16, 2018
• Primary Completion: April 20, 2019
• Study Completion: April 20, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)