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IRCT20230516058205N1 IRCT 2023-07-06 Esfahan University of Medical Sciences Evaluation of effect of spironolactone on proteinuria in kidney transplant patients Evaluation of effect of spironolactone on proteinuria in kidney transplant patients 2023-06-22 anticipated 60 Complete https://irct.ir/trial/70469 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this purpose, random allocation software and block randomization method are used. In this method, 60 eligible patients are randomly divided into 30 blocks including 2 patients. Then, each of the 2 patients in the block randomly receives spironolactone or placebo, so that 30 patients are assigned to each group, Blinding description: Patients will be divided into two groups using random allocation software. Then, for the patients in the first group as the intervention group, spironolactone 25 mg tablets will be started half daily and after one month it will be increased to one tablet daily and will be prescribed for a total of four months, and for the patients in the second group as the control group, the placebo tablets will be prescribed for four months. It is prescribed. It should be noted that in order to comply with the conditions of blinding, the two drugs spironolactone and placebo are made in advance by the pharmacist (Abourihan Pharmaceutical Company) in the same shape, size and color and are placed in similar packages and labeled A, B at the disposal of the researcher. is placed and without knowing the type of medicine, they prescribe the same in two groups. 4 Proteinuria. Intervention 1: Intervention group: For the patients in the first group as the intervention group, spironolactone 25 mg tablets will be started half daily and after one month it will be increased to one tablet daily and it will be prescribed for a total of four months,. Intervention 2: Control group: For the patients in the second group as the control group, the placebo tablets will be administered for four months. Yes - There is a plan to make this available What will be shared: All data can be released after making persons unidentifiable. When: Begining access period time from 1403. To whom: Researchers who are occupying in universities and scientific institutes Conditions: Results of this study can be used in other researches. Where to obtain: pejmanpoorshabanan@hotmail.com How to obtain: One month after receiving request , we will send the results of this study. Comments:
public Abdolamir Atapour
second apadana street
Isfahan Iran (Islamic Republic of) 8166637317 +98 31 3641 1396 pejmanpoorshabanan@hotmail.com Esfahan University of Medical Sciences scientific Abdolamir Atapour
ostandari street.Khorshid hospital
Isfahan Iran (Islamic Republic of) 8145833117 +98 31 3222 2127 abdolamiratapour@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Persons with more than three months after kidney transplantation Proteinuria more than 0.5 gram per day Estimated glomerular filtration rate more than 30 mili liter per minute Consent to participate in study 18 years no limit Both Serum potassium more than 5.5 Gynechomastia Transplant dysfunction(eGFR<30) Spironolactone usage for heart and liver failure sensitivity to spironolactone N08 Glomerular disorders in diseases classified elsewhere Treatment - Drugs Placebo Intervention group: For the patients in the first group as the intervention group, spironolactone 25 mg tablets will be started half daily and after one month it will be increased to one tablet daily and it will be prescribed for a total of four months, Control group: For the patients in the second group as the control group, the placebo tablets will be administered for four months. Urine protein. Timepoint: Monthly. Method of measurement: 24 hours urine sample. Esfahan University of Medical Sciences Approved 2023-04-18 Ethics committee of Isfan University of medical sciences Heparin jarib Isfahan Isfehan Iran (Islamic Republic of)