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IRCT20130812014333N168 IRCT 2021-05-10 Kermanshah University of Medical Sciences Comparison of the renoprotective effects of SGLT2 inhibitor (Empagliflozin) in diabetic and non-diabetic kidney transplantation patients Comparison of the renoprotective effects of SGLT2 inhibitor (Empagliflozin) in diabetic and non-diabetic kidney transplantation patients during a clinical trial at Imam Reza Educational and Medical Center in Kermanshah 2021-05-09 anticipated 28 Complete https://irct.ir/trial/55434 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table, patients are divided into two groups . Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned, Blinding description: In this single-blinded study, participants will be unaware of the allocation of study groups and the dose of received medication. Participants do not know which group will receive the new drug or placebo. 2-3 kidney transplantation. Intervention 1: The intervention group for 12 weeks will receive empagliflozin at a dose of 10 mg daily with routine treatment (500 mg metformin two or three times daily). Intervention 2: The control group for 12 weeks will receive 10 mg of placebo daily (similar in appearance to empagliflozin) with routine treatment (500 mg of metformin two or three times daily). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Seyed Mohammad Mostafavi
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 dr.mostafavi97@gmail.com Kermanshah University of Medical Sciences scientific Dr. Hossein Abdi
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 dr.mostafavi97@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Urinary protein excretion less than (<) 500 mg to 3500 mg / g in a 24-hour urine set Kidney transplant equal to or greater than 1 year ago Stable state of renal function for at least the last three months Sustained immunosuppressive therapy for at least the last 3 months 18 years no limit Both Creatinine above 2 Patients who are pregnant or are breastfeeding Patients with a history of type 1 diabetes History of more than one kidney transplant; History of severe allergies or contraindications to empagliflozin History of recurrent urinary tract infection T86.1 Complications of kidney transplant Treatment - Drugs Treatment - Drugs The intervention group for 12 weeks will receive empagliflozin at a dose of 10 mg daily with routine treatment (500 mg metformin two or three times daily). The control group for 12 weeks will receive 10 mg of placebo daily (similar in appearance to empagliflozin) with routine treatment (500 mg of metformin two or three times daily). Serum creatinine. Timepoint: The beginning of the study, the end of the 4th week, the end of the 8th week and the end of the 12th week. Method of measurement: Blood test. Urine protein content. Timepoint: The beginning of the study, the end of the 4th week, the end of the 8th week and the end of the 12th week. Method of measurement: urine test. Kermanshah University of Medical Sciences Approved 2021-03-08 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Kermanshah Kermanshah Iran (Islamic Republic of)