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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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9 January 2017 |
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Main ID: |
NCT03006952 |
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Date of registration:
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24/12/2016 |
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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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Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy
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Scientific title:
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Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03006952 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Alireza Esteghamati, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age>30 and age<70, urinary albumin excretion (UAE) =150 mg/24 h
Exclusion Criteria:
- any infectious or malignant diseases, non-diabetic kidney disease, retinal
hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable
to follow up, hyperthyroidism, baseline serum potassium concentrations =5.5 meq/L,
glomerular filtration rate (GFR)<30mL/min/1.73 m and intolerance of pentoxifylline
Age minimum:
38 Years
Age maximum:
76 Years
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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Drug: Pentoxifylline
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Drug: Losartan
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Primary Outcome(s)
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N terminal brain natriuretic peptide (NT-pro BNP)
[Time Frame: 3 months]
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Secondary Outcome(s)
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Blood pressure
[Time Frame: 3 months]
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serum creatinine concentrations
[Time Frame: 3 months]
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estimated glomerular filtration rate
[Time Frame: 3 months]
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Highly sensitive C-reactive protein (hsCRP)
[Time Frame: 3 months]
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Urinary albumin excretion
[Time Frame: 3 months]
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Secondary ID(s)
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931133003
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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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