Chronic Kidney Disease
Conditions
Keywords
Anaemia, Chronic kidney disease, Type 2 diabetes, Randomized trial
Brief summary
In type 2 diabetics, progression from chronic kidney disease to end stage renal disease may be slowed down by therapeutic interventions as angiotensin converting enzyme inhibitors use, control of high blood pressure and proteinuria, control of hyperglycaemia, protein intake restriction, smoking cessation. Correcting anaemia in these patients may prevent impairment of renal function. International guidelines indicate that haemoglobin level has to be of 110 g/L in these patients. We conduct an interventional randomized trial to evaluate the potential benefit of an haemoglobin level of 130 g/L in patients with type 2 diabetes and with a chronic kidney disease defined by a Cockcroft's creatinine clearance of 25 - 60 ml/min.
Interventions
DRUGGROUP A: if necessary, martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 110 to 129 g/L.
DRUGGROUP B: martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 130 to 149 g/L
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes. Age between 18 and 80 years, male or female. Cockcroft's clearance between 25 and 60 ml / min. Haemoglobin level superior to 100 g/L and strictly inferior to 130 g/L
Exclusion criteria
Malignancy Solid organ transplant Acute pathology in the two months before inclusion date Myocardial infarction, stroke, pulmonary embolism in the six months before inclusion date Contra-indication to martial treatment or EPO treatment Present inclusion in another clinical study Patient who cannot answer questions of SF36 questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Angina | — |
| Stroke | — |
| Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation | — |
| Heart failure | — |
| Death | — |
| Deep venous thrombosis and haemodialysis fistula thrombosis | — |
| Bacterial infectious disease | — |
| Renal replacement therapy (dialysis or pre-emptive renal transplantation) | — |
| Quality of life: SF 36 auto-questionnaire | — |
| Pulmonary embolism | — |
Countries
France
Outcome results
None listed