- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087993
Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients (IDA-I)
March 11, 2020 updated by: Dr. Frank Behrens
Randomised, Open Lable, Active Controlled Clinical Trial to Demonstrate Safety and Efficacy of an i.v. Administration of Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients With Elective Non-cardiac Surgery (IDA I)
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
Randomised, active-controlled, open-labelled, parallel group, multicentre study to demonstrate superiority of Polyglucoferron i.v.
compared to oral iron substitution for the treatment of iron deficient anaemic patients who need fast replenishment of iron stores as judged by the treating physician, e.g. if it is not appropriate to postpone surgery, before elective non-cardiac surgery and superiority of Polyglucoferron i.v.
vs Ferric Carboxymaltose in short term safety monitoring.
Study Type
Interventional
Enrollment (Anticipated)
407
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessia
-
Frankfurt, Hessia, Germany, 60590
- Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Goethe-University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female; aged ≥ 18 years
- Planned to undergo 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
- Iron deficiency defined as s-ferritin <100 ng/mL and s-transferrin saturation <20%
- Relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men
- Written informed consent; willing and able to comply with the protocol
Exclusion Criteria:
- Pregnancy in female patients or breastfeeding women
- Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
- Severe anaemia with Hb < 8 g/dL
- Any ingoing bleeding as judged by the treating physician
- Patients receiving blood transfusion 24 weeks prior screening
- Severe physical inability, e.g., American Society of Anesthesiologists (ASA) physical status IV or V
- Haematuria and proteinuria of unknown or known origin
- Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
- Anticipated medical need for erythropoiesis-stimulating agents during the study period
Patients with any contraindication to the investigational products, e.g.,
- known sensitivity to iron or an ingredient of the investigational products
- History of systemic allergic reactions
- Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
- Acute or chronic intoxication
- Infection (patient on non-prophylactic antibiotics)
- Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range
- Chronic kidney disease, defined as Glomerular Filtration Rate (GFR) <30 mL/min
- Serum Creatinine > 150 μmol/L
- Active uncontrolled immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease
- 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 summary of product characteristics (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 Ferinject 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 f) 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Polyglucoferron
once intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg
|
intravenous administration
Other Names:
|
Active Comparator: Ferric Carboxymaltose
Once intravenously (a second administration is allowed), dosing according to Hb-levels and body weight (500 - 2000 mg, max.
single dose of 1000 mg)
|
intravenous administration
Other Names:
|
Active Comparator: Ferrous sulfate
capsules, orally, dosing 50 mg - 200 mg (50 mg: 1 capsule in total, 200 mg: 4 capsules in total, taken as 2 capsules twice daily), duration of treatment 28 days
|
oral administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normalisation or Increase of hemaglobin(Hb)-level
Time Frame: baseline (BL) to day before surgery (visit 4)
|
Proportion of patients achieving normalized Hb-levels (according to World Health Organization (WHO) definition) or an increase of at least 1.5 g/dl Hb at day before surgery (visit 4) compared to baseline (BL) in the Polyglucoferron treatment arm compared to oral iron substitution with Ferrous sulfate
|
baseline (BL) to day before surgery (visit 4)
|
Detection of urine iron
Time Frame: approx. 8 hours
|
Detection of urine iron in the first urine after the end of i.v.
administration, defined as short term safety surrogate marker after administration of the i.v.
treatments
|
approx. 8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Units of allogenic red blood cell transfusion
Time Frame: baseline to visit 5 approx. 70 day
|
Proportion of units of allogenic red blood cell transfusion from BL until visit 5
|
baseline to visit 5 approx. 70 day
|
Hb values
Time Frame: baseline to visit 4 approx. 35 day
|
Mean change in Hb at visit 4 compared to BL
|
baseline to visit 4 approx. 35 day
|
Hb values
Time Frame: baseline to visit 5 approx. 70 day
|
Mean change in Hb at visit 5 compared to BL
|
baseline to visit 5 approx. 70 day
|
Transferrin Saturation (TSAT) values
Time Frame: baseline to visit 5 approx. 70 day
|
Mean change in TSAT at visit 5 compared to BL
|
baseline to visit 5 approx. 70 day
|
Transferrin Saturation (TSAT) values
Time Frame: baseline to visit 4 approx. 35 day
|
Mean change in TSAT at visit 4 compared to BL
|
baseline to visit 4 approx. 35 day
|
iron values
Time Frame: baseline to visit 4 approx. 35 day
|
Mean change in serum iron at visit 4 compared to BL
|
baseline to visit 4 approx. 35 day
|
iron values
Time Frame: baseline to visit 5 approx. 70 day
|
Mean change in serum iron at visit 5 compared to BL
|
baseline to visit 5 approx. 70 day
|
ferritin values
Time Frame: baseline to visit 5 approx. 70 day
|
Mean change in serum ferritin at visit 5 compared to BL
|
baseline to visit 5 approx. 70 day
|
ferritin values
Time Frame: baseline to visit 4 approx. 35 day
|
Mean change in serum ferritin at visit 4 compared to BL
|
baseline to visit 4 approx. 35 day
|
transferrin values
Time Frame: baseline to visit 4 approx. 35 day
|
Mean change in serum ferritin at visit 4 compared to BL
|
baseline to visit 4 approx. 35 day
|
transferrin values
Time Frame: baseline to visit 5 approx. 70 day
|
Mean change in serum ferritin at visit 5 compared to BL
|
baseline to visit 5 approx. 70 day
|
number of adverse events (AE)/serious adverse events (SAE)
Time Frame: baseline to 28 days after surgery, approx. 56 days
|
Tolerability measured by overall number of AEs/SAEs until 28 days after surgery
|
baseline to 28 days after surgery, approx. 56 days
|
incidence of adverse events (AE)/serious adverse events (SAE)
Time Frame: baseline to 28 days after surgery, approx. 56 days
|
Tolerability by incidence of AEs/SAEs until 28 days after surgery
|
baseline to 28 days after surgery, approx. 56 days
|
Seriousness of adverse events (AE)/serious adverse events (SAE)
Time Frame: baseline to 28 days after surgery, approx. 56 days
|
Overall tolerability by seriousness of AEs/SAEs until 28 days after surgery
|
baseline to 28 days after surgery, approx. 56 days
|
Relationship of adverse events (AE)/serious adverse events (SAE)
Time Frame: baseline to 28 days after surgery, approx. 56 days
|
Overall tolerability by relationship of AEs/SAEs until 28 days after surgery
|
baseline to 28 days after surgery, approx. 56 days
|
Severity of adverse events (AE)/serious adverse events (SAE)
Time Frame: baseline to 28 days after surgery, approx. 56 days
|
Overall tolerability by severity of AEs/SAEs until 28 days after surgery
|
baseline to 28 days after surgery, approx. 56 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes White blood count on each visit
|
throughout study conduction, max 77 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes in thrombocytes on each visit
|
throughout study conduction, max 77 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes in serum creatinine on each visit
|
throughout study conduction, max 77 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes in AST on each visit
|
throughout study conduction, max 77 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes in ALT on each visit
|
throughout study conduction, max 77 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes in gamma GT on each visit
|
throughout study conduction, max 77 days
|
Changes in Laboratory parameters
Time Frame: throughout study conduction, max 77 days
|
Changes in phosphate on each visit
|
throughout study conduction, max 77 days
|
Changes in vital signs
Time Frame: throughout study conduction, max 77 days
|
Changes in vital signs on each visit
|
throughout study conduction, max 77 days
|
Changes in blood pressure
Time Frame: throughout study conduction, max 77 days
|
Changes in blood pressure on each visit
|
throughout study conduction, max 77 days
|
Changes in heart rate
Time Frame: throughout study conduction, max 77 days
|
Changes in heart rate on each visit
|
throughout study conduction, max 77 days
|
Changes in physical exam
Time Frame: throughout study conduction, max 77 days
|
Changes in physical exam on each visit
|
throughout study conduction, max 77 days
|
adverse events related to administration
Time Frame: at baseline
|
AEs related to injection/infusion site reactions (i.v. group only)
|
at baseline
|
adverse events related to administration
Time Frame: 7 days after baseline, at Visit 3
|
AEs related to injection/infusion site reactions (i.v. group only)
|
7 days after baseline, at Visit 3
|
hypersensitivity reactions
Time Frame: at baseline
|
documentation of anaphylatic or anaphylactoid reactions (i.v. group only)
|
at baseline
|
hypersensitivity reactions
Time Frame: at study visit 3
|
documentation of anaphylatic or anaphylactoid reactions (i.v. group only)
|
at study visit 3
|
Mortality
Time Frame: within 28 days after surgery, approx. 56 days
|
All-cause mortality within 28 days after surgery
|
within 28 days after surgery, approx. 56 days
|
Quality of Life (SF36)
Time Frame: base line to visit 4 approx 35 days
|
Assessment of Quality of Life by SF36 questionnaire at visits 4 compared to BL
|
base line to visit 4 approx 35 days
|
Quality of Life (SF36)
Time Frame: baseline to visit 5 approx 70 days
|
Assessment of Quality of Life by SF36 questionnaire at visits 5 compared to BL
|
baseline to visit 5 approx 70 days
|
Duration of hospital stay
Time Frame: 28 days
|
Duration of hospital stay (days) until 28 days after surgery
|
28 days
|
Number of patients with normalized Hb-values
Time Frame: baseline to visit 4 approx 35 days
|
Number of patients with normalized Hb-values after iron substitution (n, %) at visits 4 and 5
|
baseline to visit 4 approx 35 days
|
Number of patients with normalized Hb-values
Time Frame: baseline to visit 5 approx 70 days
|
Number of patients with normalized Hb-values after iron substitution (n, %) at and 5
|
baseline to visit 5 approx 70 days
|
Analysis of total iron levels
Time Frame: approx 4 hours
|
Analysis of total iron levels in plasma at BL after end of iron administration (for the i.v.
groups (safety analysis group) only)
|
approx 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kai Zacharowski, Prof. MD, University Hospital of Goethe-University Frankfurt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 15, 2020
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
August 29, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMP0916_02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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