Clinical Trial Results:
Changes in Myocardial Iron Content Following Administration of Intravenous Iron
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Summary
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EudraCT number |
2016-004194-40 |
Trial protocol |
ES |
Global end of trial date |
11 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jun 2021
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First version publication date |
10 Jun 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MYOCARDIAL-IRON
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03398681 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Instituto de Investigación Sanitaria INCLIVA
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Sponsor organisation address |
Avd. Menéndez Pelayo 4, acc, Valencia, Spain, 46010
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Public contact |
Marta Peiro, Instituto de Investigación Sanitaria INCLIVA, 0034 961973536, gestioncientifica@incliva.es
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Scientific contact |
Marta Peiro, Instituto de Investigación Sanitaria INCLIVA, 0034 961973536, gestioncientifica@incliva.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Jul 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jul 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine and quantify the changes in myocardial iron content at 7 and 30-day after the administration of intravenous ferric carboxymaltose. Such changes will be assessed by T2* CMR.
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Protection of trial subjects |
The protocol, informed consent form, participant information sheet and any applicable documents were submitted and approved by an appropriate Ethics Committee
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 May 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 53
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Worldwide total number of subjects |
53
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EEA total number of subjects |
53
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
13
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From 65 to 84 years |
37
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85 years and over |
3
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Recruitment
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Recruitment details |
Patients with established Heart Failure and left ventricular ejection fraction<50% and iron deficiency | |||||||||
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Pre-assignment
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Screening details |
Patients with stablished symptomatic Heart Failure (NYHA class II-III) and iron deficiency. These patients were randomized to receive intravenous ferric carboxymaltose or placebo. All patients were recruited after signed the informed consent form. | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
53 | |||||||||
Number of subjects completed |
53 | |||||||||
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Period 1
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Period 1 title |
Randomization Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
Because ferric carboxymaltose is a dark-brown solution that is easily distinguishable from the saline placebo, study personnel responsible for the preparation and administration of the study drug awared of the group assignments and therefore, not involved in any study assessments. To ensure that patients were unaware of the study drug, materials used in drug administration were covered with aluminum foil or other opaque material and the injection site shield from the patient view.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intravenous ferric carboxymaltose | |||||||||
Arm description |
Ferric Carboxymaltose solution [Ferinject® (FCM)will be given as a perfusion of 20 mL (whi ch is the amount of FCM that is equivalent to 1000 mg of iron) diluted in a sterile saline solution (0.9% weight/volume (w/v) NaCl) administered over at least 15 min. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ferinject 50 mg / ml solution for injection and infusion
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1000 mg
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Arm title
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Placebo | |||||||||
Arm description |
Normal saline (0.9% weight/volume (w/v) NaCl) administered as per the instructions for active therapy | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Normal saline (0.9% weight/volume (w/v) NaCl
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
administered as per the instructions for active therapy.
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Baseline characteristics reporting groups
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Reporting group title |
Intravenous ferric carboxymaltose
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Reporting group description |
Ferric Carboxymaltose solution [Ferinject® (FCM)will be given as a perfusion of 20 mL (whi ch is the amount of FCM that is equivalent to 1000 mg of iron) diluted in a sterile saline solution (0.9% weight/volume (w/v) NaCl) administered over at least 15 min. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Normal saline (0.9% weight/volume (w/v) NaCl) administered as per the instructions for active therapy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intravenous ferric carboxymaltose
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Reporting group description |
Ferric Carboxymaltose solution [Ferinject® (FCM)will be given as a perfusion of 20 mL (whi ch is the amount of FCM that is equivalent to 1000 mg of iron) diluted in a sterile saline solution (0.9% weight/volume (w/v) NaCl) administered over at least 15 min. | ||
Reporting group title |
Placebo
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Reporting group description |
Normal saline (0.9% weight/volume (w/v) NaCl) administered as per the instructions for active therapy | ||
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End point title |
Changes in myocardial iron content | |||||||||
End point description |
Changes in myocardial iron content assessed by CMR T2* and T1-mapping evaluation on day 7 and day 30 after drug administration
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End point type |
Primary
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End point timeframe |
Day 7 and day 30 after drug administration
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Statistical analysis title |
Lineal Mix Model | |||||||||
Comparison groups |
Intravenous ferric carboxymaltose v Placebo
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Number of subjects included in analysis |
53
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Least square means | |||||||||
Point estimate |
5
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
5 | |||||||||
upper limit |
95 | |||||||||
Variability estimate |
Standard error of the mean
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Adverse events information [1]
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Timeframe for reporting adverse events |
Since informed consent through and including 30 calendar days after drug administration
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Intravenous ferric carboxymaltose
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Reporting group description |
Ferric Carboxymaltose solution [Ferinject® (FCM)will be given as a perfusion of 20 mL (whi ch is the amount of FCM that is equivalent to 1000 mg of iron) diluted in a sterile saline solution (0.9% weight/volume (w/v) NaCl) administered over at least 15 min. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Normal saline (0.9% weight/volume (w/v) NaCl) administered as per the instructions for active therapy | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: By protocol, non-serious adverse events were recorded |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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09 Jun 2017 |
Inclusion/ exclusion criteria modification, including verbal and legal representative conset. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/32067585 http://www.ncbi.nlm.nih.gov/pubmed/33040491 |
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