NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels

Not Applicable

• Conditions: Chronic Kidney Disease

• Registration Number: NCT00279084
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-19
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-03
• Last Update Posted: 2007-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.

Secondary Outcome Measures

Name	Time	Method
Death
Angina
Stroke
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

Trial Locations

Locations (1)

Joëlle Gillet; 🇫🇷 Lyon, France