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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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

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Conditions

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Chronic Kidney Disease

Keywords

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Anaemia Chronic kidney disease Type 2 diabetes Randomized trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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GROUP A: if necessary, martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 110 to 129 g/L.

Intervention Type DRUG

GROUP B: martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 130 to 149 g/L

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Emmanuel VILLAR, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Joëlle Gillet

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED

PMID: 21601481 (View on PubMed)

Other Identifiers

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2003.315

Identifier Type: -

Identifier Source: org_study_id