Clinical Trial Results:
Ferroglycine Sulfate Absorption in patients with Heart Failure and Iron
Deficency: an interventional before and after study.
Summary
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EudraCT number |
2017-000158-21 |
Trial protocol |
SE |
Global end of trial date |
05 Jun 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Feb 2022
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First version publication date |
09 Feb 2022
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Other versions |
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Summary report(s) |
Manuscript |
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 |
740220
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Karolinska Institutet, Södersjukhuset
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Sponsor organisation address |
Sjukhusbacken 10, Stockholm, Sweden, 118 84
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Public contact |
Clinical Trial Information, Karolinska Institutet, 46 733306965,
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Scientific contact |
Clinical Trial Information, Karolinska Institutet, 46 812363441, carin.corovic.cabrera@ki.se
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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 |
20 Jan 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jun 2020
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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 |
The main objective of the trial was to study if heart failure with iron deficiency is associated with reduced iron absorption.
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Protection of trial subjects |
Subject were given one enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+ (ATC code B03AA01) wich is a well known substans with few desciribed side effects. Venous blood samples were taken before and two hours after administration.
The study was conducted according to principles outlined in the Declaration of Helsinki and was approved by the regional Ethics Committee in Stockholm and the Swedish Medical Products Agency (EudraCT 2017-000158-21). All subjects gave their written informed consent prior to any study specific action was made. All personal data was anomymized.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Sweden: 42
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Worldwide total number of subjects |
42
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EEA total number of subjects |
42
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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) |
6
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From 65 to 84 years |
36
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
We enrolled patients with ID and known and stable CHF, objectively defined as below and with no HF hospitalization or need for iv diuretics within the previous three months. ID was defined as S-Ferritin <100 µg/L, or S-Ferritin 100-299 µg/L and transferrin saturation <20%. | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
42 | ||||||||||||
Number of subjects completed |
42 | ||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Patients with HFrEF and iron deficiency | ||||||||||||
Arm description |
Patients were divided into HF with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
One enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+
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Investigational medicinal product code |
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Other name |
ATC code B03AA01, Niferex, Erol AB
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were instructed to fast from midnight and to abstain from medications known to interact with ferroglycin sulphate (i.e. antacids, calcium supplements) until the test was finished. In the morning they were given one enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+ (ATC code B03AA01, Niferex, Erol AB)
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Arm title
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Control group | ||||||||||||
Arm description |
The controls were recruited mainly from a seniors gym and had no ID and no history, symptoms or signs of HF, normal ECG and NT-pro-BNP <125 ng/L | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
One enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+
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Investigational medicinal product code |
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Other name |
ATC code B03AA01, Niferex, Erol AB
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were instructed to fast from midnight and to abstain from medications known to interact with ferroglycin sulphate (i.e. antacids, calcium supplements) until the test was finished. In the morning they were given one enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+ (ATC code B03AA01, Niferex, Erol AB),
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Arm title
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Patients with HFpEF and iron deficiency | ||||||||||||
Arm description |
We enrolled patients with ID and known and stable CHF, objectively defined as below and with no HF hospitalization or need for iv diuretics within the previous three months. ID was defined as S-Ferritin <100 µg/L, or S-Ferritin 100-299 µg/L and transferrin saturation <20%5. Patients were divided into HF with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF). Patients with left ventricular ejection fraction (LVEF) <45% were considered to have HFrEF, and patients with LVEF ≥45% with structural and/or functional abnormalities and NT-pro-BNP >125 ng/L were considered to have HFpEF. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
One enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+
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Investigational medicinal product code |
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Other name |
ATC code B03AA01, Niferex, Erol AB
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were instructed to fast from midnight and to abstain from medications known to interact with ferroglycin sulphate (i.e. antacids, calcium supplements) until the test was finished. In the morning they were given one enterocapsule of ferroglycin sulphate complex containing 100 mg Fe2+ (ATC code B03AA01, Niferex, Erol AB)
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Baseline characteristics reporting groups
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Reporting group title |
Patients with HFrEF and iron deficiency
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Reporting group description |
Patients were divided into HF with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control group
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Reporting group description |
The controls were recruited mainly from a seniors gym and had no ID and no history, symptoms or signs of HF, normal ECG and NT-pro-BNP <125 ng/L | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Patients with HFpEF and iron deficiency
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Reporting group description |
We enrolled patients with ID and known and stable CHF, objectively defined as below and with no HF hospitalization or need for iv diuretics within the previous three months. ID was defined as S-Ferritin <100 µg/L, or S-Ferritin 100-299 µg/L and transferrin saturation <20%5. Patients were divided into HF with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF). Patients with left ventricular ejection fraction (LVEF) <45% were considered to have HFrEF, and patients with LVEF ≥45% with structural and/or functional abnormalities and NT-pro-BNP >125 ng/L were considered to have HFpEF. | |||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Overall study
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Overall study
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End points reporting groups
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Reporting group title |
Patients with HFrEF and iron deficiency
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Reporting group description |
Patients were divided into HF with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) | ||
Reporting group title |
Control group
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Reporting group description |
The controls were recruited mainly from a seniors gym and had no ID and no history, symptoms or signs of HF, normal ECG and NT-pro-BNP <125 ng/L | ||
Reporting group title |
Patients with HFpEF and iron deficiency
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Reporting group description |
We enrolled patients with ID and known and stable CHF, objectively defined as below and with no HF hospitalization or need for iv diuretics within the previous three months. ID was defined as S-Ferritin <100 µg/L, or S-Ferritin 100-299 µg/L and transferrin saturation <20%5. Patients were divided into HF with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF). Patients with left ventricular ejection fraction (LVEF) <45% were considered to have HFrEF, and patients with LVEF ≥45% with structural and/or functional abnormalities and NT-pro-BNP >125 ng/L were considered to have HFpEF. | ||
Subject analysis set title |
Overall study
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Overall study
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End point title |
The absolute increase of P-iron after two hours compared to baseline | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The absolute increase of P-iron after two hours compared to baseline
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Statistical analysis title |
Mann Whitney U test | ||||||||||||||||
Statistical analysis description |
The non-parametric test Mann Whitney U was used for hypothesis testing and Kruskal-Wallis was used to compare differences between the three groups in baseline characteristics. A two-sided overall α<0.05 was considered to be significant. Analyses were performed with the use of IBM SPSS Statistics 25.
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Comparison groups |
Patients with HFrEF and iron deficiency v Control group v Patients with HFpEF and iron deficiency
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Mann Whitney U tast | ||||||||||||||||
Confidence interval |
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Notes [1] - The non-parametric test Mann Whitney U was used for hypothesis testing and Kruskal-Wallis was used to compare differences between the three groups in baseline characteristics. A two-sided overall α<0.05 was considered to be significant. Analyses were performed with the use of IBM SPSS Statistics 25. |
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Adverse events information
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Timeframe for reporting adverse events |
Subjects were contacted one week after the study procedure to report any adverse events. Subjects were also encuraged to report any adverse event to the study team.
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
20
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Reporting groups
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Reporting group title |
AE report
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Reporting group description |
- | ||||||||||||||
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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? No | |||
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 |