Clinical Trial Results:
Exploratory multicentre prospective double blinded randomised controlled pilot study of the effect of intravenous iron supplementation(Monofer)in iron deficient but not anaemic patients with Chronic Kidney Disease stages 3b or worse on functional status and cardiac structure and function.
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Summary
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EudraCT number |
2014-004133-16 |
Trial protocol |
GB |
Global end of trial date |
21 May 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
21 May 2022
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First version publication date |
21 May 2022
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Other versions |
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Summary report(s) |
doi: 10.1186/s12882-021-02308-y |
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 |
R1766
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Hull University Teaching Hospitals NHS Trust
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Sponsor organisation address |
Castle Road, Cottingham, United Kingdom, HU16 5JQ
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Public contact |
Research and Development Office , Hull University Teaching Hospitals NHS Trust , +44 01482 461903, research.development@hey.nhs.uk
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Scientific contact |
Academic Renal Research Office , Hull University Teaching Hospitals NHS Trust , +44 01482 605260, sunil.bhandari@hey.nhs.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 |
21 May 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 May 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
21 May 2019
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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 whether IV iron supplementation in iron deficient non-anaemic CKD patients improves physical and functional status assessed by the 6MWT and questionnaires (KDQoL and MLHF).
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Protection of trial subjects |
Safety assessment will occur continuously throughout the trial. Medical history at baseline
will be recorded. A Physical examination along with blood sampling for routine biochemistry
paying particular attention to renal excretory function and electrolytes as in the attached
Table. Participants will be contacted by phone by a study nurse after 1 week for a safety
assessment and evidence of adverse events will be sought at each routine follow-up visit.
The participant will be asked to contact their study nurse if they have any concerns about
safety at any time in between routine follow-up visits for the trial.
Serious adverse events will be identified and documented on the CRF at routine visits,
based on participant reports and primary or secondary care reports. In addition, episodes of
infection requiring hospitalisation and other infection episodes will be documented. In
addition, haemoglobin, ferritin, platelet levels, and other laboratory measurements detailed
above will be monitored.
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Background therapy |
Intravenous saline was used as placebo for this trial. No other treatment was used in the trial apart from the trial drug and placebo. | ||
Evidence for comparator |
Trial evidence on the effectiveness and safety of Monofer® in CKD is sparse but expanding; this is reflected in current guidelines, which provide no specific didactic instructions for its administration in patients with CKD. Thus, the proposed trial logically follows on from initial studies, and proposes an exploratory randomized double blinded placebo controlled pilot trial (using dummy solution normal saline without the added drug) in patients with CKD stages G3b to 5 (pre-dialysis) to address this issue further and fill the gap in knowledge. Also within the trial are mechanistic studies which will add to and advance our scientific understanding of these data. | ||
Actual start date of recruitment |
02 Mar 2015
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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 |
United Kingdom: 54
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Worldwide total number of subjects |
54
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EEA total number of subjects |
0
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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) |
54
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants will be recruited from at least 3 renal units in the UK. Currently, patients with CKD under the care of a nephrologist are reviewed every 3-4 months in a hospital outpatient clinic. Potential trial participants will be identified when presenting for their routine hospital clinic visits. This reflects the proposed research care. | |||||||||
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Pre-assignment
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Screening details |
Fifty–four patients aged 18 years or over with CKD (stage G3b to G5) will be enrolled. Each patient must meet all of the inclusion criteria, and none of the exclusion criteria, at entry to the trial. Patients who meet the entry criteria may be recruited by the investigator or any medically qualified member of the local trial team who has delegated. | |||||||||
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Period 1
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Period 1 title |
Visit 1
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test | |||||||||
Arm description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
IV Monofer 1g
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of
Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single
total dose infusion.
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Arm title
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Placebo | |||||||||
Arm description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
0.9% Saline solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion.
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Period 2
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Period 2 title |
Visit 2
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Is this the baseline period? |
Yes [1] | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IV Monofer 1g
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of
Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single
total dose infusion.
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
0.9% Saline solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion.
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| Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Visit 1 is the screening visit performed at week -4 to -2 to ensure compliance with the eligibility criteria. |
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Period 3
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Period 3 title |
Visit 3
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test | |||||||||
Arm description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
IV Monofer 1g
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of
Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single
total dose infusion.
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Arm title
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Placebo | |||||||||
Arm description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
0.9% Saline solution
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion.
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Period 4
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Period 4 title |
Visit 4
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test | |||||||||
Arm description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
IV Monofer 1g
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of
Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single
total dose infusion.
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Arm title
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Placebo | |||||||||
Arm description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
0.9% Saline solution
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion.
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Period 5
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Period 5 title |
Visit 5
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test | |||||||||
Arm description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
IV Monofer 1g
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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|||||||||
Dosage and administration details |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of
Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single
total dose infusion.
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Arm title
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Placebo | |||||||||
Arm description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
0.9% Saline solution
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion.
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End points reporting groups
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Reporting group title |
Test
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Reporting group description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Test
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Test
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Reporting group description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Test
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Reporting group description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Test
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Reporting group description |
Addition of IV Monofer® 1g. Patient will receive 100ml of normal saline 0.9% with addition of Iron Isomaltoside (Monofer®) 1000mg infused intravenously over 30 minutes as a single total dose infusion. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo – IV inert solution (no iron therapy). Patient will receive placebo (100ml of normal saline 0.9% only) infused intravenously over 30 minutes as a single total dose infusion. | ||
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End point title |
6MWT | ||||||||||||||||||||
End point description |
Adjusting for baseline 6MWT, the 6MWT in the main
study participants at 1 month and 3 months showed no
statistically significant difference between FDI and placebo arms (p = 0.736 and 0.741 respectively). (Fig. 1).
Analysis of change in 6MWT showed that the mean
(SD) change for FDI patients from baseline to 3 months
was 6.0 (89.1) metres compared to 1.9 (111.2) metres for
the placebo arm patients (Suppl Table 1). During follow
up there was a greater than 25 m increase in 6MWT observed in 8/22 (36.4%) of patients at 1 month and 10/20
(50%) at 3 months in the FDI arm vs 8/25 (32% - 1
month) and 10/24 (41.7% - 3 months) patients in the
placebo arm, respectively (p = 0.753, p = 0.580).
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End point type |
Primary
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End point timeframe |
1month and 3 month
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| Notes [1] - Some participant's could not perform the 6 minute walking test due to other health conditions. [2] - Some participant's could not perform the 6 minute walking test due to other health conditions. [3] - Some participant's could not perform the 6 minute walking test due to other health conditions. [4] - Some participant's could not perform the 6 minute walking test due to other health conditions. |
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Statistical analysis title |
Change from baseline to 1 month, 6MWT | ||||||||||||||||||||
Comparison groups |
Test v Placebo
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Number of subjects included in analysis |
47
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||||||
Method |
Chi-squared corrected | ||||||||||||||||||||
Parameter type |
N/A | ||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
90% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||||||||||
upper limit |
0 | ||||||||||||||||||||
Statistical analysis title |
Change from baseline to 1 month, 6MWT | ||||||||||||||||||||
Comparison groups |
Test v Placebo
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||||||
P-value |
= 0.895 | ||||||||||||||||||||
Method |
Chi-squared | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
90% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||||||||||
upper limit |
0 | ||||||||||||||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
Safety assessment will occur continuously throughout the trial and at each follow-up.
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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 |
15.1
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Reporting groups
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Reporting group title |
Test (IV Iron)
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Reporting group description |
Arm of the trial under test. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Arm of the study under placebo. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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20 Jan 2016 |
Protocol
• Protocol page 18 – Condoms have been added to the list of acceptable contraceptives in the first exclusion criterion
• Protocol page 18 – Added ‘N.B. Women of childbearing potential using condoms only as a contraceptive method will require a pregnancy test at the baseline visit, prior to administration of Monofer® therapy’ to first exclusion criterion
• Protocol page 21 – Added ‘Women of childbearing potential using condoms only as a contraceptive method will additionally require a pregnancy test at the baseline visit, prior to administration of Monofer® therapy.’
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07 Dec 2016 |
Protocol
• In the original CT application, Question A28 “Will any participants be recruited by publicity through posters, leaflets, adverts or websites?” was answered “No”. This has now been changed to “Yes”. The study may now be advertised on patient facing websites and newsletters.
• The number of patients in, Control Group 2 – patients with Chronic Kidney Disease without iron deficiency and anaemia, has been reduced from 20 to 10. This reduction in size does not affect the primary outcome.
The following non-substantial amendments were also made:
• An extension to the end date of study from 01.04.16 to 01.07.18.
• In the Safety Reporting section of the protocol we have added some clarification to the type of infection that requires recording in the Case Report Form.
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27 Mar 2017 |
Protocol
• This amendment only affects the Hull site.
Page numbers amended: 14, 16, 20, 21, 22, 35 and 39.
The number of patients in the parallel sub-study (Group 4) has been changed from 6 to 4.
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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 | |||
