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

NCT00279084 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2007-10-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Emmanuel VILLAR, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00279084 on ClinicalTrials.gov