Clinical Trial Results:
Multicentre prospective double blinded randomised controlled trial of the effect of intravenous iron supplementation and exercise training in Iron deficient, but not anaemic, patients with Chronic Kidney Disease on exercise capacity, physical function, fatigue and skeletal muscle metabolism.
Summary
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EudraCT number |
2018-000144-25 |
Trial protocol |
GB |
Global end of trial date |
11 Mar 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Dec 2023
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First version publication date |
08 Dec 2023
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Other versions |
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Summary report(s) |
Summary report |
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 |
234820
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
King's College Hospital NHS Foundation Trust
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Sponsor organisation address |
Denmark Hill, London, United Kingdom, SE5 9RS
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Public contact |
Dr Kate Bramham, King's College Hospital, 44 (0)2032996233, kate.bramham@kcl.ac.uk
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Scientific contact |
Dr Kate Bramham, King's College Hospital, 44 (0)2032996233, kate.bramham@kcl.ac.uk
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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 |
11 Mar 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Mar 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Mar 2022
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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 assess the effect of intravenous iron on exercise capacity, as assessed by 6-minute walking distance, with and without exercise training in patients with chronic kidney disease and iron deficiency, but without anaemia.
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Protection of trial subjects |
Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study treatment in the event of intercurrent illness, AEs, SAE’s, SUSAR’s, protocol violations, administrative reasons or other reasons. The role of the trial steering committee for this trial was to provide independent oversight of ethical and safety aspects of the trial and to advise the steering committee on acceptable continuation of the study, or whether the study should be stopped.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 May 2019
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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 |
United Kingdom: 75
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Worldwide total number of subjects |
75
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EEA total number of subjects |
75
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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) |
49
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From 65 to 84 years |
26
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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 |
- | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
75 | |||||||||||||||
Number of subjects completed |
75 | |||||||||||||||
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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IV iron | |||||||||||||||
Arm description |
For all patients the total iron dose will be 1000mg as a one off infusion in 100ml normal saline administered over a minimum of 15 minutes. The final volume should be 100 ml. In order to achieve this, first remove 20ml from the 100 ml normal saline before adding the 20 ml vial of Ferinject, | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
ferinject
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
For all patients the total iron dose will be 1000mg as a one off infusion in 100ml normal saline administered over a minimum of 15 minutes.
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Arm title
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Placebo | |||||||||||||||
Arm description |
Placebo patients will receive 100ml normal saline administered over a minimum of 15 minutes. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Placebo patients will receive 100ml normal saline administered over a minimum of 15 minutes.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IV iron
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Reporting group description |
For all patients the total iron dose will be 1000mg as a one off infusion in 100ml normal saline administered over a minimum of 15 minutes. The final volume should be 100 ml. In order to achieve this, first remove 20ml from the 100 ml normal saline before adding the 20 ml vial of Ferinject, | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo patients will receive 100ml normal saline administered over a minimum of 15 minutes. |
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End point title |
6 minute walk test [1] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline to week 4
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please see attached report |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Baseline to week 12
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26
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Reporting groups
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Reporting group title |
IV iron
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Reporting group description |
For all patients the total iron dose will be 1000mg as a one off infusion in 100ml normal saline administered over a minimum of 15 minutes. The final volume should be 100 ml. In order to achieve this, first remove 20ml from the 100 ml normal saline before adding the 20 ml vial of Ferinject, | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo patients will receive 100ml normal saline administered over a minimum of 15 minutes. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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17 Jul 2019 |
CI Change |
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07 Dec 2021 |
RSI update |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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/35896969 |