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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: |
NCT02194790 |
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Date of registration:
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17/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
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Scientific title:
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Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting. |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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238 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02194790 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Kotcharat Vipattawat, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bhumirajanagarindra Kidney Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diabetic patients with eGFR are equal or more than 60 ml/min/1.73m2 estimated twice
at 3 months.
Exclusion Criteria:
- Active glomerular disease, obstructive uropathy, end-stage renal disease, HIV
infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being
under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g
creatinine and active urinary sediment (urine red blood cells >3 cells/high power
field or urine white blood cells >10 cells/high power field).
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Nephropathy
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Chronic Kidney Disease
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Intervention(s)
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Behavioral: Community-based Integrated CKD Care
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Primary Outcome(s)
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The difference of rate of estimated glomerular filtration(eGFR) decline
[Time Frame: 12 months]
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Secondary Outcome(s)
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Change from baseline in systolic blood pressure
[Time Frame: 12 months]
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Change from baseline in waist circumference
[Time Frame: 12 months]
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Change from baseline in low density lipoproteins(LDL)
[Time Frame: 12 months]
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Change from baseline in Random Urine Albumin to Creatinine Ratio
[Time Frame: 12 months]
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Change from baseline in Hemoglobin A1C
[Time Frame: 12 months]
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Secondary ID(s)
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CICC program
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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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