Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Treatments group a: if necessary, martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 110 to 129 g/l., group b: martial treatment and / or erythropoietin treatment to achieve the goal of haemoglobin level from 130 to 149 g/l
Sponsor Hospices Civils de Lyon
Start date January 2004
Trial size 204 participants
Trial identifier NCT00279084, 2003.315

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.
time frame:

Secondary Outcomes

Measure
Death
time frame:
Angina
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Stroke
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Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation
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Heart failure
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Pulmonary embolism
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Deep venous thrombosis and haemodialysis fistula thrombosis
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Bacterial infectious disease
time frame:
Renal replacement therapy (dialysis or pre-emptive renal transplantation)
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Quality of life: SF 36 auto-questionnaire
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Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Emmanuel VILLAR, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.