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IRCT20090905002417N23 IRCT 2020-02-01 Esfahan University of Medical Sciences Effect of Linagliptin on diabetic proteinuria Effect of Linagliptin on Proteinuria in Diabetic Renal Disease patients 2019-03-21 anticipated 140 Complete https://irct.ir/trial/40907 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The numbers are divided to 2 groups: study and placebo according to table of random numbers via software. this numbers have 4 parts. First participate receive first 4 digit number, second person receive second 4 digit number and .....They receive drug or placebo according to codes. The study is a double blind because the patients and coordinator do not know there is drug or placebo. Principal investigator design random numbers and get to coordinator. Only principal investigator know which package is drug or placebo and he do not have any role in data analysis.It is a double blind study, Blinding description: Drug & placebo will be given to care provider. these drugs are similar together and are given to participant. care provider & participant are blinded about drug. 3 Proteinuria in diabetic patients with chronic kidney disease. Intervention 1: Intervention group: Linagliptin ( Melijent), Linagliptin molecule, 5mg tablet, one tablet daily for 6 months, irrespective to diet, manufactured by Alhavi pharmaceutic, IRAN. Intervention 2: Control group: Placebo tablet, 5 mg, daily for 6 months, manufactured by Alhavi pharmaceutic, IRAN. Yes - There is a plan to make this available What will be shared: Analyzed data will be available When: starting 6 months after publication To whom: this only available for people working in academic institutions Conditions: In response to requests via email sending, only analysis and results will send to person via person responsible for scientific inquiries. Using the analysis without reference indicating is forbidden. email: fimoinzad@yahoo.com Where to obtain: Requests via email sending to person responsible for scientific inquiries address: fimoinzad@yahoo.com . How to obtain: After receiving email, it will be responsed Comments:
public Firouzeh Moeinzadeh
Sofe street, Alzahra hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 6713 f_moinzade@med.mui.ac.ir Esfahan University of Medical Sciences scientific Firouzeh Moeinzadeh
Sofe street, Alzahra hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 6713 fimoinzad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diabetes Mellitus eGFR between 30-60cc/min/1.73m2 Proteinuria more than 300mg/d Not use Immunosuppressive drugs( cyclosporin, tacrolimus, mycophenolate, azathioprin, methotrexate) inactive urine sediment 18 years 90 years Both Hypoglycemia HbA1C less than 6% E08.22 Diabetes mellitus due to underlying condition with diabetic chronic kidney disease Treatment - Drugs Placebo Intervention group: Linagliptin ( Melijent), Linagliptin molecule, 5mg tablet, one tablet daily for 6 months, irrespective to diet, manufactured by Alhavi pharmaceutic, IRAN Control group: Placebo tablet, 5 mg, daily for 6 months, manufactured by Alhavi pharmaceutic, IRAN Proteinuria. Timepoint: before intervention and 3 & 6 months later. Method of measurement: urine 24 hours collection. Serum creatinin. Timepoint: before intervention and 3 & 6 months later. Method of measurement: laboratory kit ELISA. Systolic blood pressure. Timepoint: before intervention and 3 & 6 months later. Method of measurement: Digital sphygmomonometer. Diastolic blood pressure. Timepoint: before intervention and 3 & 6 months later. Method of measurement: Digital sphygmomonometer. Hemoglobin A1C. Timepoint: before intervention and 3 & 6 months later. Method of measurement: laboratory kit ELISA. Fasting blood suger. Timepoint: before intervention and 3 & 6 months later. Method of measurement: laboratory kit. Esfahan University of Medical Sciences Approved 2018-09-02 Ethics committee of Isfahan University of Medical Sciences Sofe Ave. Isfahan Kidney Diseases Research Center, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)