EUCTR2018-000144-25-GBActive, not recruitingPhase 1
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
King's College Hospital NHS Foundation Trust0 sites70 target enrollmentStarted: January 28, 2019Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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
- •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 < 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 <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
Investigators
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