pre-operative iron deficiency in patients with planned elective surgery and pre-/post-operative iron deficiency anamia MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851
Conditions
Interventions
Product Name: Feramyl
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Iron (III) hydroxide hydroxyethyl starch glucoheptonic acid complex
CAS Number: CAS 15
Other descriptive name: IRO
Sponsors
Fraunhofer Gesellschaft for its Institute Fraunhofer für Translationale Medizin und Pharmakologie (ITMP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female; aged = 18 years • Patients with planned surgery(e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) • Confirmed and documented preoperative iron deficiency defined as S-ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 203
Exclusion criteria
Exclusion criteria: • Pregnancy in female patients or breastfeeding women • Female patients not willing to use a safe method of contraception (PEARL index 50% as indicator of iron overload o Acute or chronic intoxication o Infection (patient on non-prophylactic antibiotics) o Chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range • Chronic kidney disease, defined as GFR <30 mL/min • Immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease if active and uncontrolled • Primary haematologic disease • Drug or alcohol abuse according to WHO definition • Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study • Current or previous participation in another clinical trial during the last 90 days before screening Exclusion criteria related to Ferrous sulfate: • according to SmPC • hypersensitivity to any ingredient in the formulation • concomitant parenteral iron • haemochromatosis, and other iron overload syndromes Exclusion criteria related to Ferric Carboxymaltose: • according to SmPC • hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients • known serious hypersensitivity to other parenteral iron products • anaemia not attributed to iron deficiency • evidence of iron overload or disturbances in the utilisation of iron Exclusion criteria related to Polyglucoferron: • hypersensitivity to any ingredient in the formulation • known serious hypersensitivity to other parenteral iron products • anaemia not attributed to iron deficiency • evidence of iron overload or disturbances in the utilisation of iron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To demonstrate superiority of i.v. iron substitution with Polyglucoferron compared to oral iron therapy with Ferrous sulfate in focus on proportion of patients who achieve normalized Hb-levels (according to WHO definition) or increased Hb-level with at least 1.5 g/dl 28 days at visit 4 compared to BL 2) To demonstrate superiority in short term safety assessed of statistically significant lower levels of volume-corrected urine iron, estimated by the difference in v.c. iron urine measured before and after i.v. administration (first urine after the end of i.v. administration) of Polyglucoferron compared to Ferric Carboxymaltose;Secondary Objective: •Treatment effects on changes in haematologic and serologic iron parameters (Hb,TSAT,s-iron,s-transferrin,s-ferritin) from BL until V4 •Proportion of patients with normalization (WHO) of Hb at V4 •Treatment effects of Polyglucoferron i.v. and Ferric Carboxymaltose i.v. on s-phosphate levels at V4 •Overall tolerability and number, incidence, seriousness, severity and relationship of AEs/SAEs until 30d after last IMP •Changes in laboratory parameters, vital signs and physical exam on each visit incl. blood pressure and heart rate •AEs related to injection/infusion site reactions (i.v. groups) and hypersensitivity reactions •All-cause mortality until V4 •The need of allogenic RBC transfusion (number of units and number of patients) from BL until V4 •Treatment effect on change in Quality of Life (SF-36) at V4 compared to BL •Duration of hospital stay (days) until V4 •Analysis of total iron levels in plasma at BL after end of iron administration (for i.v. safety analysis group);Primary end point(s): 1) Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl in the Polyglucoferron i.v. arm compared to oral iron substitution with Ferrous sulfate at visit 4 compared to BL 2) Pre-post difference of volume-corrected urine iron levels measured before and in the first urine a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints for efficacy: • Proportion of patients with normalization (defined in WHO classification) of Hb at visit 4 • Mean change in Hb, TSAT, s-iron, s-transferrin and s-ferritin until visit 4 Secondary endpoints for safety: • Mean change in s-phosphate levels at visits 4 (i.v. groups only) • Overall tolerability and number, incidence, seriousness, severity, relationship of AEs/SAEs until 30 days after last IMP administration • Changes in laboratory parameters, vital signs, and physical exam on each visit including blood pressure and heart rate • AEs related to injection/ infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions • All-cause mortality until visit 4 Exploratory efficacy endpoints: • Proportion of units of allogenic red blood cell transfusion from BL until visit 4 • treatment effect on Quality of Life (SF36) at visit 4 compared to BL • Duration of hospital stay (days) until visit 4 • Analysis of total iron levels in plasma at BL after end of iron administration [for the i.v. groups (safety analysis group) only];Timepoint(s) of evaluation of this end point: BL/V2, V3 and V4 | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Research
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Outcome results
None listed