Clinical trial • Cardiology

FERRIC DERISOMALTOSE for Iron deficiency anaemia

Clinical trial of FERRIC DERISOMALTOSE for Iron deficiency anaemia.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Iron deficiency anaemia
Drug Modality
Other|Small molecule

Key dates

Initial CTIS Submission Date
31-07-2024
First CTIS Authorization Date
22-08-2024

Trial design

Randomised, 0.9% sodium chloride intravenous infusion solution (placebo); maximum total volume 250 ml; route: intravenous.-controlled trial across 4 sites in Netherlands.

Randomised
Yes
Comparator
0.9% Sodium Chloride Intravenous Infusion Solution (placebo); maximum total volume 250 ml; route: intravenous.
Target Sample Size
310
Trial Duration For Participant
90

Eligibility

Recruits 310 No vulnerable populations selected. Inclusion requires 'Mentally competent with age ≥ 70 years' (participants are older adults and must be mentally competent)..

Vulnerable Population
No vulnerable populations selected. Inclusion requires 'Mentally competent with age ≥ 70 years' (participants are older adults and must be mentally competent).

Inclusion criteria

  • {"criterion_text":"- Mentally competent with age ≥ 70 years\n- Elective AVR or CABG surgery (including AVR or CABG surgery combined with rhythm surgery, i.e. maze, pulmonary vein isolation and left auricular ear amputation)\n- Expected uncomplicated postoperative trajectory, defined as:\n- No inotropic agents or ventilation at time of final inclusion (POD 1)\n- Expected discharge to general ward at POD 1\n- Moderate postoperative IDA, defined as:\n- Hb between 85 and 110 g/L and\n- Ferritin <100 μg/L or\n- Iron saturation (TSAT) < 20%"}

Exclusion criteria

  • {"criterion_text":"- Medical history of iron overload/haemochromatosis\n- Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)\n- Severe renal failure (eGFR<15ml/min/1.73m2)\n- Recent treatment with IVI (<12 weeks prior)\n- Serious or severe allergic reaction to IVI in medical history\n- Severe asthma or eczema in medical history (atopic constitution)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at POD 90 after elective cardiac surgery.","definition_or_measurement_approach":"Disability measured by the 12-item World Health Organization Disability Assessment score 2.0 (WHODAS-12) at postoperative day (POD) 90 after elective cardiac surgery."}

Secondary endpoints

  • {"endpoint_text":"- Postoperative RBC transfusions\n- Change in reticulocyte hemoglobin content from randomization to hospital discharge\n- Hb levels at hospital discharge\n- Hospital complications according to the Nederlandse Hart Registratie (NHR)\n- Days alive and out of hospital at POD 90\n- Change in PROMs regarding dyspnoea symptoms at POD 90 (assessed with the RDS)","definition_or_measurement_approach":"Postoperative RBC transfusions (count of transfusions); change in reticulocyte hemoglobin content measured from randomization to hospital discharge; Hb levels measured at hospital discharge; hospital complications adjudicated/recorded according to the Nederlandse Hart Registratie (NHR); days alive and out of hospital measured at POD 90; PROMs for dyspnoea at POD 90 assessed with the Rose Dyspnea Score (RDS)."}

Recruitment

Planned Sample Size
310
Recruitment Window Months
63
Consent Approach
Subject information and informed consent form document is present ('L1 SIS ICF EUCT2024 5159203501'). Participants are required to be mentally competent (age ≥ 70 years) and will provide consent themselves. Specific languages and assent details are not provided in the available data.

Geography

Total Number Of Sites
4
Total Number Of Participants
310

Netherlands

Earliest CTIS Part Ii Submission Date
22-08-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
0
Number Of Sites
4
Number Of Participants
310

Sites

Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Anaesthesia
Principal Investigator Name
Peter Noordzij
Principal Investigator Email
p.noordzij@antoniusziekenhuis.nl
Contact Person Name
Peter Noordzij
Site Name
Amphia Hospital
Department Name
Anaesthesia
Principal Investigator Name
Thijs Rettig
Principal Investigator Email
trettig@amphia.nl
Contact Person Name
Thijs Rettig
Contact Person Email
trettig@amphia.nl
Site Name
Stichting OLVG
Department Name
Anaesthesia
Principal Investigator Name
Marc Godfried
Principal Investigator Email
m.b.godfried@olvg.nl
Contact Person Name
Marc Godfried
Contact Person Email
m.b.godfried@olvg.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Anaesthesia
Principal Investigator Name
Maarten Ter Horst
Principal Investigator Email
m.terhorst@erasmusmc.nl
Contact Person Name
Maarten Ter Horst
Contact Person Email
m.terhorst@erasmusmc.nl

Sponsor

Primary sponsor

Full Name
Sint Antonius Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Monofer 100 mg/ml oplossing voor injectie/infusie
Active Substance
FERRIC DERISOMALTOSE
Modality
Other
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation present (marketingAuthNumber: RVG 103070)
Maximum Dose
20 mg/kg
Investigational Product Name
0.9% Sodium Chloride Intravenous Infusion Solution
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation present (marketingAuthNumber: PA1968/018/001)
Maximum Dose
250 ml

Related trials

Other published trials that may interest you.