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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00279084
First received: January 18, 2006
Last updated: October 3, 2007
Last verified: October 2007
  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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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

Secondary Outcome Measures:
  • 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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00279084

Locations
France
Joëlle Gillet
Lyon, France, 69376
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Emmanuel VILLAR, MD Hospices Civils de Lyon
  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:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014