Clinical trial NCT00279084: NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Anaemia
Chronic kidney disease
Type 2 diabetes
Randomized trial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.
Secondary outcomes:
measure: Death
measure: Angina
measure: Stroke
measure: Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation
measure: Heart failure
measure: Pulmonary embolism
measure: Deep venous thrombosis and haemodialysis fistula thrombosis
measure: Bacterial infectious disease
measure: Renal replacement therapy (dialysis or pre-emptive renal transplantation)
measure: Quality of life: SF 36 auto-questionnaire
Other outcomes:
Locations:
city: Lyon
country: France
facility: Joëlle Gillet
Study officials:
affiliation: Hospices Civils de Lyon
name: Emmanuel VILLAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villar E, Lievre M, Kessler M, Lemaitre V, Alamartine E, Rodier M, Francois M, Zaoui P, Moranne O, Choukroun G, Guerraoui A, Jolivot A, Janin G, Branger B, Heng AE, Boudray C, Bissery A, Rabilloud M, Pouteil-Noble C. Anemia normalization in patients with type 2 diabetes and chronic kidney disease: results of the NEPHRODIAB2 randomized trial. J Diabetes Complications. 2011 Jul-Aug;25(4):237-43. doi: 10.1016/j.jdiacomp.2011.03.003. Epub 2011 May 20.