NEPHRODIAB2 Prospective Randomized Controlled Open-Labelled Trial Comparing Effect of Two Haemoglobin Levels
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- Decrease in Cockcroft's creatinine clearance between inclusion and end of two years follow-up period.
- Death
- Angina
- Stroke
- Peripheral acute ischemia, vascular angioplasty, surgical vascular bypass, amputation
- Heart failure
- Pulmonary embolism
- Deep venous thrombosis and haemodialysis fistula thrombosis
- Bacterial infectious disease
- Renal replacement therapy (dialysis or pre-emptive renal transplantation)
- Quality of life: SF 36 auto-questionnaire
| Estimated Enrollment: | 204 |
| Study Start Date: | January 2004 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided by Hospices Civils de Lyon
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00279084 History of Changes |
| Other Study ID Numbers: | 2003.315 |
| Study First Received: | January 18, 2006 |
| Last Updated: | October 3, 2007 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Hospices Civils de Lyon:
|
Anaemia Chronic kidney disease Type 2 diabetes Randomized trial |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012
