Table 1 Inclusion and exclusion criteria
Inclusion criteria: | Exclusion criteria: |
|---|---|
• Patients with stage 3–4 CKD | • Pregnancy or breast feeding (female patients of childbearing age were asked if there was any possibility, they may be pregnant) |
• Resting BP ≤ 160/95 mmHg | • Body mass < 50 kg |
• Serum ferritin level less than 100 µg/L AND/OR transferrin saturation ≤ 20% | • Kidney, kidney-pancreas and liver transplant patients |
• Haemoglobin 110–150 g/L | • Patients with known allergy to iron therapy |
• male or female | • Haemochromatosis, porphyria cutanea tarda or history of acquired iron overload |
• Aged 18–80 years | • History of intravenous iron within previous 6 weeks |
• Able to provide written informed consent | • Patients with CRP > 50 mg/L |
|  | • Patients with serum phosphate < 0.7 mmol/L |
|  | • Active infection |
|  | • Current therapy with ESAs |
|  | • Current oral, intravenous or topical (on legs) immunosuppressive treatment or use within previous 3 months |
|  | • 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 |
|  | • Patients with known severe aortic stenosis or pacemaker in-situ |
|  | • History of severe atopy |
|  | • Severe liver disease with serum transaminases >  × 3 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 to be a contraindication to IV iron |