drugset
drugset / Trial / NCT04087993

Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients

NCT04087993 ↗

Phase 3 Withdrawn Dr. Frank Behrens IRON4U · collabUniversity Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling · collabUniversity Hospital Frankfurt, Department of Anaesthesiology · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with IDA and for whom fast replenishment of iron stores is necessary, e.g. if its not appropriated to postpone surgery, will be identified within 28 to 42 days before surgery. Patients will be randomised to receive either Polyglucoferron intravenously (i.v.), Ferric Carboxymaltose i.v. or oral iron substitution with Ferrous sulfate.

Timeline

Start
2020-05-15
Primary completion
2020-12-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric carboxymaltose Other / unclassified 500 mg Intravenous
Comparator Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Comparator Ferric carboxymaltose Other / unclassified 2000 mg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 50 mg Oral
Comparator Ferrous Sulfate Diagnostic / imaging agent 200 mg Oral
Subject Polyglucoferron Unknown 500 mg Intravenous
Subject Polyglucoferron Unknown 2000 mg Intravenous

Indications

iron deficiency anemia