preoperative iron deficiency anaemia in patients with planned elective non-cardiac surgery 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: IR
Sponsors
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female; aged = 18 years 2.Planned to undergo elective non-cardiac surgery (e.g., orthopaedic, vascular, visceral surgery) within 28 to 42 days, which requires a fast replenishment of the patients’ iron stores (e.g. if it is not appropriate to postpone surgery) as judged by the treating physician 3.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: 1.Pregnancy in female patients or breastfeeding women 2.Female patients not willing to use a safe method of contraception (PEARL index 50% as indicator of iron overload d)Acute or chronic intoxication e)Infection (patient on non-prophylactic antibiotics) f)Chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range 11.Chronic kidney disease, defined as GFR 150 µmol/L 13.Active uncontrolled immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease 14.Primary haematologic disease 15.Drug or alcohol abuse according to WHO definition 16.Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study 17.Current or previous participation in another clinical trial during the last 90 days before screening 18.Exclusion criteria related to Ferrous sulfate a)according to SmPC b)hypersensitivity to any ingredient in the formulation c)concomitant parenteral iron d)haemochromatosis, and other iron overload syndromes 19.Exclusion criteria related to Ferric Carboxymaltose: a)according to SmPC b)hypersensitivity to the active substance, to Ferinject or any of its excipients c)known serious hypersensitivity to other parenteral iron products d)anaemia not attributed to iron deficiency e)evidence of iron overload or disturbances in the utilisation of iron 20.Exclusion criteria related to Polyglucoferron a)hypersensitivity to any ingredient in the formulation b)known serious hypersensitivity to other parenteral iron products c)anaemia not attributed to iron deficiency d)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 an increased Hb of at least 1.5 g/dl at day before surgery compared to BL 2) To demonstrate superiority in short term safety assessed by measurements of statistically significant lower levels of urine iron after i.v. administration of Polyglucoferron compared to Ferric Carboxymaltose, measured in the first urine after the end of i.v. administration;Secondary Objective: -Need of allogenic red blood cell transfusion (number of units and number of patients) from BL until 28 days after surgery -Treatment effects on haematologic and serologic iron parameters (Hb, TSAT, s-iron, s-ferritin, s-transferrin) from baseline (BL) until day before surgery (V4) and V5 -Overall tolerability and number, incidence, seriousness, severity and relationship of AEs/SAEs until 28 days after surgery -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. groups only) and hypersensitivity reaction -All-cause mortality within 28 days after surgery -Treatment effect on Quality of Life (SF36) at V4 and V5 compared to BL -Duration of hospital stay until 28 days after surgery -Number of patients with normalized Hb-values after iron substitution (n, %) at V4 and V5 -Analysis of total iron levels in plasma at BL after end of i.v. iron administration;Primary end point(s): 1) Proportion of patients achieving normalized Hb-levels (according to WHO definition) or an increase of at least 1.5 g/dl Hb at day before surgery (visit 4) compared to BL in the Polyglucoferron treatment arm compared to oral iron substitution 2) Detection of urine iron in the first urine after the end of i.v. administration, defined as short term safety surrogate ma | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints for efficacy: - Proportion of units of allogenic red blood cell transfusion from BL until visit 5 - Mean change in Hb, TSAT, s-iron, s-ferritin and s-transferrin at vistis 4 and 5 compared to BL Secondary endpoints for safety: - Overall tolerability and number, incidence, seriousness, severity, and relationship of AEs/SAEs until 28 days after surgery (visit 5) - 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. groups only) and hypersensitivity reactions - All-cause mortality within 28 days after surgery Exploratory efficacy endpoints: - Quality of Life (SF36) at visits 4 and 5 compared to BL - Duration of hospital stay (days) until 28 days after surgery - Number of patients with normalized Hb-values after iron substitution (n, %) at visits 4 and 5 - 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 (28-35 days before surgery), V4 (day before surgery), V5 (28-35 days after surgery) | — |
Countries
Austria, Germany, United Kingdom
Contacts
Public ContactBranch for TMP
Fraunhofer IME, Translational Medicine and Pharmacology
Outcome results
None listed