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

NCT00279084 | Unknown

• 1 other identifier: 2003.315
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Anaemia; Chronic kidney disease; Type 2 diabetes; Randomized trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

• Death

• Angina

• Stroke

• Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation

• Heart failure

Interventions

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 DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Joëlle Gillet

Lyon, 69376, France

Location

Related Publications (1)

• 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.

  PMID: 21601481 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Emmanuel VILLAR, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 19, 2006
• Study Start: January 1, 2004
• Last Updated: October 4, 2007

Record last verified: 2007-10

Locations

FR (1)