The Iron and Muscle Study

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. - Iron and Muscle

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000144-25-GB

Enrollment

Registered

2019-01-28

Start date

2019-03-08

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency in stage 3-4 CKD MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: LLT Classification code 10066763 Term: Chronic iron deficiency anaemia System Organ Class: 100000004851

Interventions

Trade Name: Ferrinject Product Name: Ferrinject Pharmaceutical Form: Injection INN or Proposed INN: Ferric carboxymaltose CAS Number: 00

Eligibility

Sex/Gender

All

Inclusion criteria

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 • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: •Pregnancy or breast feeding (Female patients of child bearing 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 50 mg/L •Serum phosphate x3 upper limit of normal range according to local laboratory values. •Severe lung disease with FEV1 known to be <50% predicted in last year •Known heart failure with a left ventricular ejection fraction <45% in last year •Any other health condition considered by the local Principal Investigator in which IV iron will be contraindicated. •Insufficient understanding of the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.; Secondary Objective: 1) To assess physical capacity, quality-of-life, and skeletal muscle metabolism in patients with chronic kidney disease and iron and deficiency, but without anaemia. 2) To determine if iron repletion enhances the effect of an 8-week exercise programme when compared to placebo treatment. ;Primary end point(s): The 6-minute Walking distance test (in metres) - An exercise capacity test.;Timepoint(s) of evaluation of this end point: Baseline, 4 weeks and 12 weeks.	—

Measure

Time frame

Main Objective: 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.; Secondary Objective: 1) To assess physical capacity, quality-of-life, and skeletal muscle metabolism in patients with chronic kidney disease and iron and deficiency, but without anaemia. 2) To determine if iron repletion enhances the effect of an 8-week exercise programme when compared to placebo treatment. ;Primary end point(s): The 6-minute Walking distance test (in metres) - An exercise capacity test.;Timepoint(s) of evaluation of this end point: Baseline, 4 weeks and 12 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): •Iron status (Ferritin, TSAT) and haemoglobin •Renal function (urea, creatinine, estimated glomerular filtration rate) •VO2 peak test (in a sub-set of participants) •Isokinetic dynamometry (muscle strength) •Chalder Fatigue Questionnaire -- physical and mental fatigue •Functional capacity (sit-to-stand 60 to assess lower limb function) •Quality of life (KDQOL-36) •Skeletal muscle phosphocreatine recovery halftime (PCr t1/2) on MRI spectroscopy (n=40 patients at baseline and 4 weeks) •Muscle metabolism •Patient recruitment and retention •Qualitative exploration of participant experience •The Work and Social Adjustment Scale (WSAS) •Adverse events ;Timepoint(s) of evaluation of this end point: All at baseline, 4 weeks and 12 weeks except for muscle metabolism which will be at baseline and 4 weeks.	—

Measure

Time frame

Secondary end point(s): •Iron status (Ferritin, TSAT) and haemoglobin •Renal function (urea, creatinine, estimated glomerular filtration rate) •VO2 peak test (in a sub-set of participants) •Isokinetic dynamometry (muscle strength) •Chalder Fatigue Questionnaire -- physical and mental fatigue •Functional capacity (sit-to-stand 60 to assess lower limb function) •Quality of life (KDQOL-36) •Skeletal muscle phosphocreatine recovery halftime (PCr t1/2) on MRI spectroscopy (n=40 patients at baseline and 4 weeks) •Muscle metabolism •Patient recruitment and retention •Qualitative exploration of participant experience •The Work and Social Adjustment Scale (WSAS) •Adverse events ;Timepoint(s) of evaluation of this end point: All at baseline, 4 weeks and 12 weeks except for muscle metabolism which will be at baseline and 4 weeks.

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Countries

United Kingdom

Contacts

Public ContactDr Kate Bramham

King's College Hospital

kate.bramham@kcl.ac.uk44(0)2032996233

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026