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Clinical Trial Details

Trial ID: L1380
Source ID: NCT03664414
Associated Drug: Pentoxifylline
Title: Pentoxifylline Effect in Patients With Diabetic Nephropathy.(PENFOSIDINE STUDY)
Acronym: PENFOSIDINE
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Kidney Disease stage3 and 4|Type 2 Diabetes Mellitus
Interventions: DRUG: pentoxifylline
Outcome Measures: Primary: Change in the glomerular filtration rate, It will be measure as to duplicate serum creatinine levels from baseline (mg/dL), or to pass from a stage of chronic kidney disease to he next stage (GFR mL/min), The measurements will be done baseline and every six months up to 24 months. | Secondary: Change in oxidative stress marker., The change in vit C level from baseline (normal range 4-8.8mg/ L), Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.|Change in fibrosis markers., Change in Nt_ProBNP from the baseline (Normal values up to 381 pg/mL), Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.|Change in inflammation markers., To assess inflammation high sensitivity C reactive protein will be measured by nephelometry. (normal value \< 5 mg/L, Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.|Change in health-related quality of life, This outcome will be measured by the SF 36 questionnaire, themaximun punctuation is 100, as greater punctuation a better quality of life, The questionnaire will be applied baseline and every six months up to 24 months.
Sponsor/Collaborators: Sponsor: Maria Eugenia Galván Plata | Collaborators: Centro de Investigación Biomédica de Michoacán.|Hospital General Regional N° 1 Instituto Mexicano del Seguro Social.|Hospital General de Zona N° 83 Instituto Mexicano del Seguro Social.|Coordinación Auxiliar Medica de Investigación en Salud. Delegación Michoacán.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 196
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-03-01
Completion Date: 2021-12-31
Results First Posted:
Last Update Posted: 2019-02-07
Locations: Cibimi - Hgz 83 Imss, Morelia, Michoacán, 58290, Mexico
URL: https://clinicaltrials.gov/show/NCT03664414