The Iron and Muscle Study (NCT04862715) | Clinical Trial Compass
CompletedPhase 4
The Iron and Muscle Study
United Kingdom75 participantsStarted 2019-04-26
Plain-language summary
This is a multi-center randomized controlled trial that will examine the efficacy of IV iron supplementation when compared to placebo, with and without exercise training, on changes in patient exercise capacity. The study aims to provide sufficient data to inform a power calculation for the definitive study to examine whether IV iron therapy in patients with CKD stages 3-4 (non-dialysis) can improve exercise capacity, muscle metabolism and physical function. Specifically, we propose to examine whether a strategy of IV iron therapy in patients with stages 3-4 CKD who are iron-deficient but NOT anaemic leads to improvements in exercise capacity.
Very little is currently known about the effects of iron deficiency on cardiac or skeletal muscle metabolism in patients suffering from CKD. Nevertheless, it seems likely that iron deficiency will contribute to mitochondrial dysfunction and reduced energy production in cardiac or skeletal muscle of CKD patients, and importantly may contribute to the reduced exercise capacity, physical function and overwhelming fatigue commonly reported in this population. The results of this trial will provide data to ascertain whether intravenous iron therapy might be beneficial to exercise capacity, muscle metabolism, physical function, and fatigue and whether iron repletion enhances the effect of an exercise intervention.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with established CKD (Stages 3-4) not on dialysis
* Resting BP ≤ 160/95mmHg
* Men and women aged 18 - 80 years
* Serum ferritin level less than 100μg/L AND/OR transferrin saturation ≤20%
* Haemoglobin 110 - 150 g/L
Exclusion Criteria:
* Pregnancy or breast feeding (Female patients of childbearing age will be asked if there is any possibility they may be pregnant. This is standard of care and no pregnancy test will be requested unless there is doubt about this. IV iron is given to many pregnant patients in standard treatment and there is no evidence of harm to mother or foetus).
* Weight \< 50kg
* Known allergy to iron therapy
* Haemochromatosis, porphyria cutanea tarda or history of acquired iron overload
* Intravenous iron within previous 6 weeks
* CRP \> 50 mg/L
* Serum phosphate \< 0.7 mmol/L.
* Active infection
* Current therapy with ESAs
* Uncontrolled atrial fibrillation
* Use of anticoagulants in those under consideration for muscle biopsy
* Unstable angina or heart attack within the last year
* Presence of solid organ cancer
* Known haemoglobinopathy, myelodysplasia, or myeloma
* Patients with peripheral vascular or musculoskeletal disease, who the investigator deems unable to carry out the 6MWT.
* Known severe aortic stenosis and pacemaker in-situ
* History of severe atopy
* Severe liver disease with serum transaminases \> x3 upper limit of normal range according to local laboratory values.
* Severe lung disease with FEV1 known to be…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Exercise capacity as measured by 6 minute walk distance (6MWD)