Anaemia in diabetic nephropathy Haematological Disorders Anaemia
Conditions
Interventions
All patients should be iron replete (i.e. ferritin 0.1 or Tsats 0.2%) before randomisation. Participants will be given intravenous (IV) iron to replete iron stores if required before randomisation.
P
Sponsors
Barts and the London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with diabetic nephropathy and chronic kidney disease III and IV 2. Age more than 18 years and less than 80 years 3. Haemoglobin less than 11.5 g/dl
Exclusion criteria
Exclusion criteria: 1. Current treatment with an erythropoiesis-stimulating agent (ESA) 2. Uncontrolled hypertension 3. Congestive cardiac failure 4. History of seizures 5. History of thrombotic episodes 6. Pregnancy 7. Lactation 8. Presence of systemic disease, infection or inflammatory conditions 9. Hepatic insufficiency 10. Active hepatitis 11. Uncontrolled hypothyroidism 12. Chronic alcoholism 13. Known hypersensitivity to the active substance in the cartridge or benzoic acid 14. Known sensitivity to epoetin beta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of decline of renal function as determined by estimated glomerular filtration rate (GFR) 2. Composite end-point of: 2.1. Doubling of creatinine 2.2. Reaching end-stage renal failure 2.3. Death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in left ventricular hypertrophy as measured on echocardiogram 2. Change in intimal and medial wall thickness as determined by intimal thickness and flow dependant vasodilation as determined by ultrasound 3. Change in functional quality of life scores 4. Change in markers of endothelial dysfunction 5. Change of markers of tubular damage in the urine | — |
Countries
United Kingdom
Outcome results
None listed