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IRCT20230607058409N1 IRCT 2023-06-15 Shahid Beheshti University of Medical Sciences Investigating the effect of empagliflozin and melijent in chronic kidney failure patients Comparison of the effect of empagliflozin and metformin with Melijent and metformin in chronic kidney failure patients 2023-06-22 anticipated 150 Complete https://irct.ir/trial/70655 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is convinient and based on the block randomization (Double block )method, individually and using the Rand function of Excel software eligible patients will be divided into two treatment groups according to the determined plan (RCT plan). All people eligible to enter the study will be randomly assigned to one of the two drug receiving groups with a ratio of 1:1, Blinding description: This study is double-blind. The drugs needed for the people participating in the study will be sent to the treatment center from the manufacturing company in a completely covered and indistinguishable form for use by patients. All drugs (empagliflozin and Melijent) are similar in shape and color and are taken daily. The people participating in the study and the person in charge of data analysis will not be aware of the division of empagliflozin and melijent group. 1-2 Diabetic patients. Intervention 1: When the researcher ensures that the candidate is suitable for entering the study according to all the inclusion and non-entry criteria, the candidate will be placed in one of the following 2 intervention groups based on the predetermined random plan; To ensure acceptance and safety, the drug will be prescribed by an internal specialist. Intervention group one: administration of metformin + empagliflozin Patients in both groups will be followed up for a maximum of 6 months in three occasions (one, three and 6 months after the intervention) during the study. All the results of the study will be reviewed and recorded at zero (before the start of the study (drug administration)) and monthly until the end of 6 months after receiving the intervention (one, three, 6 months after the intervention).Patients treated with empagliflozin 10 mg which are manufactured by Obeidi company. Intervention 2: Intervention group: When the researcher ensures that the candidate is suitable for entering the study according to all the inclusion and non-entry criteria, the candidate will be placed in one of the following 2 intervention groups based on the predetermined random plan; To ensure acceptance and safety, the drug will be prescribed by an internal specialist. Intervention group one: administration of metformin + empagliflozin, intervention group two (active control): administration of metformin + Patients in both groups will be followed up for a maximum of 6 months in three occasions (one, three and 6 months after the intervention) during the study. All the results of the study will be reviewed and recorded at zero (before the start of the study (drug administration)) and monthly until the end of 6 months after receiving the intervention (one, three, 6 months after the intervention )with melijent 5 mg, both of which are manufactured by Obeidi company. Yes - There is a plan to make this available What will be shared: Potential data can be shared after de-identifying individuals When: The access period begins 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions Conditions: It will be available only to researchers working in academic and scientific institutions Where to obtain: Imam Hossein Hospital Research and Research Unit We will respond to the postal address of Imam Hossein Hospital 617763141 or through the researcher's e-mail rezaappleapp@gmail.com. How to obtain: The request should be sent to the researcher's email (Rezaappleapp@gmail.com) Comments:
public reza zeinabadi noghabi
Shahid Madani Street, Imam Hossein Hospital
tehran Iran (Islamic Republic of) 1617763141 +98 915 156 2940 rezaappleapp@gmail.com Shahid Beheshti University of Medical Sciences scientific reza zeinabadi noghabi
Shahid Madani Street, Imam Hossein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 915 156 2940 rezaappleapp@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) -Patients with over 20mL/min/1.73m2 (calculated by MDRD formula) in the first visit Patient over 18 years old patients -Patients with less 60 ml /min/1.73m2 (calculated by MDRD formula) in the first visit 18 years 75 years Both Class four congestive heart failure Recurrent urinary infection Myocardial infarction, stroke, transient ischemic attack E11.2 Type 2 diabetes mellitus with kidney complications Treatment - Drugs Treatment - Drugs When the researcher ensures that the candidate is suitable for entering the study according to all the inclusion and non-entry criteria, the candidate will be placed in one of the following 2 intervention groups based on the predetermined random plan; To ensure acceptance and safety, the drug will be prescribed by an internal specialist. Intervention group one: administration of metformin + empagliflozin Patients in both groups will be followed up for a maximum of 6 months in three occasions (one, three and 6 months after the intervention) during the study. All the results of the study will be reviewed and recorded at zero (before the start of the study (drug administration)) and monthly until the end of 6 months after receiving the intervention (one, three, 6 months after the intervention).Patients treated with empagliflozin 10 mg which are manufactured by Obeidi company. Intervention group: When the researcher ensures that the candidate is suitable for entering the study according to all the inclusion and non-entry criteria, the candidate will be placed in one of the following 2 intervention groups based on the predetermined random plan; To ensure acceptance and safety, the drug will be prescribed by an internal specialist. Intervention group one: administration of metformin + empagliflozin, intervention group two (active control): administration of metformin + Patients in both groups will be followed up for a maximum of 6 months in three occasions (one, three and 6 months after the intervention) during the study. All the results of the study will be reviewed and recorded at zero (before the start of the study (drug administration)) and monthly until the end of 6 months after receiving the intervention (one, three, 6 months after the intervention )with melijent 5 mg, both of which are manufactured by Obeidi company. 1) Examination of renal function (GFR). Timepoint: The effect of improving the renal function of GFR at the beginning of the study (before the start of the intervention) 3 and 6 months after the start of the drugs. Method of measurement: 140-Age*weight/ creatinine plasma*72. The amount of proteinuria. Timepoint: The amount of proteinuria at the beginning of the study (before the start of the intervention) 3 and 6 months after the start of the drugs. Method of measurement: 24-hour proteinuria (mg/dl). Blood pressure. Timepoint: Blood pressure at the beginning of the study (before the start of the intervention) 3 and 6 months after the start of the drugs. Method of measurement: Mercury pressure gauge. Fasting sugar. Timepoint: Fasting blood sugar levels at the beginning of the study (before the start of the intervention) 3 and 6 months after the start of the drugs. Method of measurement: Fasting blood sugar test (mg/dl). ir.sbmu.msp.rec.1402.113 دانشگاه علوم پزشکی شهید بهشتی Shahid Beheshti University of Medical Sciences Approved 2023-06-10 Ethics Committee of Shahid Beheshti University of Medical Sciences Imam Hossein Hospital, Shahid Madani St tehran Tehran Iran (Islamic Republic of)