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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00306436 |
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Date of registration:
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21/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comprehensive Management of Diabetic Patients With Renal Impairment : Impact on Blood Pressure and Glycemic Control
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Scientific title:
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Evaluation of the Impact of a Comprehensive Clinical Management on the Quality of Blood Pressure and Glycemic Control in Diabetic Uremic Patients |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00306436 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Catherine Lasseur, Doctor |
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Address:
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Telephone:
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33 (0) 5 56 79 55 37 |
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Email:
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catherine.lasseur@chu-bordeaux.fr |
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Affiliation:
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Name:
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Geneviève Chêne, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Name:
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Catherine Lasseur, doctor |
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Address:
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Telephone:
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33 (0) 5 56 79 55 37 |
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Email:
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catherine.lasseur@chu-bordeaux.fr |
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Affiliation:
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Name:
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Catherine Lasseur, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diabetic patients affected by renal insufficiency defined by glomerular filtration
rate < 60 ml/min/1,73 m² by the Cockcroft-Gault formula
- signed informed consent
Exclusion Criteria:
- pregnant woman
- minors
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Nephropathies
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Intervention(s)
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Procedure: comprehensive management
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Primary Outcome(s)
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composite criteria reflecting a good glycemic and arterial pressure status. Success defined by all measurements of HbA1c < 6.5% and of systolic (diastolic) pressure <=135 (85) mmHg if proteinuria is < 1g/24h or <= 125 (75) if proteinuria is => 1g/24h
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Secondary ID(s)
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9286-01
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2001-027
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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