NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels
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.
Chronic Kidney Disease
Drug: GROUP A: if necessary, martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 110 to 129 g/L.
Drug: GROUP B: martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 130 to 149 g/L
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels (110- 129 g/L and 130 - 149 g/L) on Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes and With Chronic Kidney Disease|
- Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.
- Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation
- Heart failure
- Pulmonary embolism
- 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
|Study Start Date:||January 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279084
|Lyon, France, 69376|
|Principal Investigator:||Emmanuel VILLAR, MD||Hospices Civils de Lyon|